Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT00730327
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2008-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.eaton@apolloendo.com', 'phone': '949-468-9301', 'title': 'Laura Eaton, Study Director, RN, BSN, CCRN-R,', 'organization': 'Apollo Endosurgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) data was collected over a period of 12 months.', 'description': 'AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.', 'eventGroups': [{'id': 'EG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise', 'otherNumAtRisk': 125, 'otherNumAffected': 124, 'seriousNumAtRisk': 125, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise', 'otherNumAtRisk': 130, 'otherNumAffected': 92, 'seriousNumAtRisk': 130, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 81, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroesophageal Reflux Disease (GERD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 112, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 97, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Post procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood thyroid stimulating hormone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vitamin B1 decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Chronic myelogenous leukemia', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Syncope', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperparathyroidism', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Irritable bowel syndrome', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventral hernia', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diverticulitis', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Device Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric outlet obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Defective device', 'notes': 'Abdominal cramping due to defective device (bacterial overgrowth).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Choledocholithiasis', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Giardia lamblia infection', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Viral gastroparesis', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Osteoarthritis of the hip', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysmenorrhea', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Breast abscess', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ovarian cyst', 'notes': 'Event determined to be not-device related for BIB group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Laryngospasm', 'notes': 'Laryngospasm during BIB placement (procedure-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hemithyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sphincter of Oddi dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Motor vehicle accident with nasal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Herniated lumbar disc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal cell carcinoma with nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bilateral vertebral artery hypoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Excess Weight Loss (%EWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '26.52', 'spread': '20.70', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '15.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.\n\nPercent EWL was calculated as %EWL= (weight loss divided by excess weight)\\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.', 'unitOfMeasure': 'percentage of EWL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).'}, {'type': 'PRIMARY', 'title': 'Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': '15% EWL over the control group mean', 'categories': [{'measurements': [{'value': '45.60', 'groupId': 'OG000', 'lowerLimit': '36.67', 'upperLimit': '54.75'}]}]}, {'title': '25% EWL over the control group mean', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '24.67', 'upperLimit': '41.77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.\n\n%EWL= (weight loss divided by excess weight) \\* 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.\n\nIdeal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.', 'unitOfMeasure': 'percentage of BIB participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Comorbid Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': 'Diabetes-Baseline (BIB n=124, Control n=130)', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Diabetes-Week 26 (BIB n=100, Control n=94)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Diabetes-Week 39 (BIB n=102, Control n=94)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Diabetes-Week 52 (BIB n=95, Control n=94)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-Baseline (BIB n=125, Control n=130)', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '28.5', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-Week 26 (BIB n=124, Control n=91)', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-Week 39 (BIB n=91, Control n=95)', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension-Week 52 (BIB n=98, Control n=92)', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}]}]}, {'title': 'Dyslipidemia-Baseline (BIB n=125, Control n=130)', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'Dyslipidemia-Week 26 (BIB n=102, Control n=94)', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'Dyslipidemia-Week 39 (BIB n=102, Control n=95)', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG001'}]}]}, {'title': 'Dyslipidemia-Week 52 (BIB n=96, Control n=94)', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '26.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': "The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.\n\nComorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.\n\nHypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.\n\nDyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL \\<50 mg/dL (male) or \\<40 mg/dL (female).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': 'Physical Func-Baseline (BIB n=122, Control n=130)', 'categories': [{'measurements': [{'value': '71.4', 'spread': '22.09', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '21.14', 'groupId': 'OG001'}]}]}, {'title': 'Physical Func-Week 39 (BIB n=98, Control n=92)', 'categories': [{'measurements': [{'value': '90.0', 'spread': '14.26', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'Role Physical-Baseline (BIB n=123, Control n=130)', 'categories': [{'measurements': [{'value': '78.5', 'spread': '21.59', 'groupId': 'OG000'}, {'value': '80.3', 'spread': '23.07', 'groupId': 'OG001'}]}]}, {'title': 'Role Physical-Week 39 (BIB n=98, Control n=93)', 'categories': [{'measurements': [{'value': '93.0', 'spread': '13.56', 'groupId': 'OG000'}, {'value': '85.6', 'spread': '20.89', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain-Baseline (BIB n=123, Control n=130)', 'categories': [{'measurements': [{'value': '72.8', 'spread': '21.88', 'groupId': 'OG000'}, {'value': '75.4', 'spread': '22.34', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain-Week 39 (BIB n=99, Control n=93)', 'categories': [{'measurements': [{'value': '84.9', 'spread': '18.84', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '23.91', 'groupId': 'OG001'}]}]}, {'title': 'General Health-Baseline (BIB n=123, Control n=128)', 'categories': [{'measurements': [{'value': '61.9', 'spread': '20.22', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '20.11', 'groupId': 'OG001'}]}]}, {'title': 'General Health-Week 39 (BIB n=99, Control n=93)', 'categories': [{'measurements': [{'value': '79.1', 'spread': '16.53', 'groupId': 'OG000'}, {'value': '68.6', 'spread': '20.67', 'groupId': 'OG001'}]}]}, {'title': 'Vitality-Baseline (BIB n=123, Control n=130)', 'categories': [{'measurements': [{'value': '52.7', 'spread': '18.19', 'groupId': 'OG000'}, {'value': '53.0', 'spread': '19.11', 'groupId': 'OG001'}]}]}, {'title': 'Vitality-Week 39 (BIB n=99, Control n=93)', 'categories': [{'measurements': [{'value': '67.6', 'spread': '17.74', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '21.08', 'groupId': 'OG001'}]}]}, {'title': 'Social Func-Baseline (BIB n=123, Control n=130)', 'categories': [{'measurements': [{'value': '80.5', 'spread': '21.89', 'groupId': 'OG000'}, {'value': '80.8', 'spread': '23.30', 'groupId': 'OG001'}]}]}, {'title': 'Social Func-Week 39 (BIB n=99, Control n=93)', 'categories': [{'measurements': [{'value': '92.6', 'spread': '13.35', 'groupId': 'OG000'}, {'value': '83.3', 'spread': '22.14', 'groupId': 'OG001'}]}]}, {'title': 'Role Emotional-Baseline (BIB n=123, Control n=130)', 'categories': [{'measurements': [{'value': '84.0', 'spread': '22.65', 'groupId': 'OG000'}, {'value': '84.6', 'spread': '20.81', 'groupId': 'OG001'}]}]}, {'title': 'Role Emotional-Week 39 (BIB n=98, Control n=93)', 'categories': [{'measurements': [{'value': '92.2', 'spread': '15.55', 'groupId': 'OG000'}, {'value': '86.8', 'spread': '19.75', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health-Baseline (BIB n=123, Control n=130)', 'categories': [{'measurements': [{'value': '74.0', 'spread': '17.91', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '16.60', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health-Week 39 (BIB n=99, Control n=93)', 'categories': [{'measurements': [{'value': '80.1', 'spread': '15.82', 'groupId': 'OG000'}, {'value': '72.5', 'spread': '18.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 39', 'description': "The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life (IWQOL-Lite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': 'Baseline (BIB n=121, Control n=127)', 'categories': [{'measurements': [{'value': '68.40', 'spread': '18.733', 'groupId': 'OG000'}, {'value': '68.55', 'spread': '17.356', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (BIB n=103, Control n=94)', 'categories': [{'measurements': [{'value': '84.64', 'spread': '12.888', 'groupId': 'OG000'}, {'value': '76.67', 'spread': '16.472', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (BIB n=99, Control n=93)', 'categories': [{'measurements': [{'value': '85.78', 'spread': '14.411', 'groupId': 'OG000'}, {'value': '78.58', 'spread': '16.833', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (BIB n=97, Control n=94)', 'categories': [{'measurements': [{'value': '85.79', 'spread': '15.424', 'groupId': 'OG000'}, {'value': '79.85', 'spread': '16.189', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': "The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).'}, {'type': 'SECONDARY', 'title': 'Change in Participant Depression (Beck Depression Inventory II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': 'Baseline (BIB n=124, Control n=130)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '7.92', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '7.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (BIB n=104, Control n=95)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '8.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (BIB n=99, Control n=93)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '5.12', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '6.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (BIB n=97, Control n=95)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '7.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': 'Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)'}, {'type': 'POST_HOC', 'title': 'Change in BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': 'Baseline (BIB n=125, Control n=130)', 'categories': [{'measurements': [{'value': '35.20', 'spread': '3.165', 'groupId': 'OG000'}, {'value': '35.43', 'spread': '2.650', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (BIB n=117, Control n=91)', 'categories': [{'measurements': [{'value': '31.43', 'spread': '3.762', 'groupId': 'OG000'}, {'value': '33.61', 'spread': '3.253', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (BIB n=91, Control n=95)', 'categories': [{'measurements': [{'value': '31.85', 'spread': '4.035', 'groupId': 'OG000'}, {'value': '33.83', 'spread': '3.300', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (BIB n=98, Control n=92)', 'categories': [{'measurements': [{'value': '32.50', 'spread': '4.177', 'groupId': 'OG000'}, {'value': '33.96', 'spread': '3.517', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': "Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).", 'unitOfMeasure': 'kg/m²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).'}, {'type': 'POST_HOC', 'title': 'Percent EWL (Using BMI=25 kg/m²)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': 'Week 26 (BIB n=117, Control n=91)', 'categories': [{'measurements': [{'value': '38.4', 'spread': '27.61', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '18.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (BIB n=91, Control n=95)', 'categories': [{'measurements': [{'value': '34.6', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '19.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (BIB n=98, Control n=92)', 'categories': [{'measurements': [{'value': '29.0', 'spread': '30.70', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '20.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': "Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).\n\nPercent EWL was calculated as %EWL= (weight loss divided by excess weight)\\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25.", 'unitOfMeasure': 'percentage of EWL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)'}, {'type': 'POST_HOC', 'title': 'Percent Total Body Weight Loss (%TBWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'classes': [{'title': 'Week 26 (BIB n=117, Control n=91)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '11.4'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '4.2'}]}]}, {'title': 'Week 39 (BIB n=91, Control n=93)5', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '10.3'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '4.3'}]}]}, {'title': 'Week 52 (BIB n=98, Control n=92)', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '8.9'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': "Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).", 'unitOfMeasure': 'percentage of TBWL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Started is defined as subjects that began treatment.', 'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'Completed Week 26', 'achievements': [{'comment': 'Week 26 was halfway through the study, at which point the BIB group had their balloon removed.', 'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed defined as subjects who completed the Week 52 follow-up visit.', 'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Subject withdrew (reason not specified)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Patients were enrolled at 15 investigational sites across the US, between 6/20/2008 and 10/10/2010. Patients were either enrolled as run-in subjects (mentored cases which were enrolled prior to randomized subjects in order for physicians to gain experience with placing and removing the device) or as subjects for randomization.', 'preAssignmentDetails': '448 subjects were enrolled (defined as signing the informed consent), 44 of which were run-in subjects. Prior to randomization, 131 subjects were screen failures. 273 subjects were randomized to the BIB (137) and control groups (136). 12 BIB and 6 control subjects discontinued prior to treatment. 125 BIB and 130 control subjects began treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.\n\nBioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.\n\nBehavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-19 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '20-29 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': '60 years & over', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Black (not of Hispanic origin)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'title': 'BMI <30', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'BMI ≥30 and <35', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'BMI ≥35 and ≤40', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'BMI >40', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Subject BMI (kg/m²) was calculated using their baseline weight at screening. Subjects with BMI\\<30 or \\>40 were major protocol deviations', 'unitOfMeasure': 'participants'}, {'title': 'Number of Years Obese', 'classes': [{'title': '< 5 years obese', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': '5-9 years obese', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': '10-19 years obese', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': '20-29 years obese', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': '30-39 years obese', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '40-49 years obese', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '50 years obese & over', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The baseline analysis population consisted of the Intent-to-Treat (ITT) population. All baseline characteristics were calculated at the screening visit.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2008-08-06', 'resultsFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-08', 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Excess Weight Loss (%EWL)', 'timeFrame': '9 months', 'description': 'The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.\n\nPercent EWL was calculated as %EWL= (weight loss divided by excess weight)\\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.'}, {'measure': 'Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group', 'timeFrame': '9 months', 'description': 'The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.\n\n%EWL= (weight loss divided by excess weight) \\* 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.\n\nIdeal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants With Comorbid Conditions', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': "The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.\n\nComorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.\n\nHypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.\n\nDyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL \\<50 mg/dL (male) or \\<40 mg/dL (female)."}, {'measure': 'Change in Quality of Life (SF-36)', 'timeFrame': 'Baseline, Week 39', 'description': "The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores."}, {'measure': 'Change in Quality of Life (IWQOL-Lite)', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': "The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints."}, {'measure': 'Change in Participant Depression (Beck Depression Inventory II)', 'timeFrame': 'Baseline, Week 26, Week 39, Week 52', 'description': 'Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '27465076', 'type': 'DERIVED', 'citation': 'Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a BMI ≥ 30 and ≤ 40;\n* Be male or female, between 18 and 65 years of age, inclusive;\n* Have a history of obesity (BMI ≥ 30 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;\n* Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;\n* Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 26 weeks);\n* Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing;\n* Must be willing to take prescribed proton pump inhibitors (PPIs)and other medications as prescribed by the investigator;\n* Be able to provide written informed consent and authorization for use and release of Health and Research Study Information;\n* Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.\n\nExclusion Criteria:\n\n* Any surgery of the foregut excluding uncomplicated cholecystectomy\n* History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy), GI obstruction, adhesive peritonitis, and/or hiatal hernia (\\>/= 2 cm);\n* A patulous pyloric channel;\n* History or symptoms of esophageal or GI motility disorders (not just those with \\<40%) as these patients are particularly susceptible to the development of esophagitis;\n* History or previous symptoms of delayed Gastric Emptying (GE) and/or delayed GE having been documented on a previously performed gastric scintigraphy study or another previously performed diagnostic study such as a UGI x-ray series;\n* Current symptoms of delayed GE;\n* A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation);\n* Anemia defined as a hemoglobin value for females of \\<11.3 g/dl and for males \\< 13.0 g/dl;\n* History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;\n* History or symptoms of inflammatory bowel disease, such as Crohn's disease or Ulcerative Colitis;\n* History or symptoms of uncontrolled or unstable thyroid disease;\n* Subjects with a positive test for Helicobacter pylori (H.p.) at screening; subjects may participate in the study if, prior to randomization, they are treated with a pharmacological regimen designed to eradicate their H.p. and subsequently have a negative H.p. breath test indicating that the H.p. has been eradicated\n* History or symptoms in the past 24 months of significant irritable bowel syndrome, peritonitis, active esophagitis, gastritis and/or duodenitis, gastric or duodenal ulceration, GI hemorrhage, or GI bleeding;\n* Type I diabetes;\n* Placement of previous intragastric balloon or similar device;\n* Ongoing treatment with anticoagulants, steroids, aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastroduodenal mucosal irritants or to reduce GI motility, and/or an unwillingness to discontinue the use of these concomitant medications;\n* Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study;\n* Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia;\n* Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential;\n* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study;\n* Poor general health, presence of a specific condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and/or placement of the BIB, or may interfere significantly with the subject's participation in the study (e.g., HIV, Hepatitis C, or cancer history within the last 5 years)"}, 'identificationModule': {'nctId': 'NCT00730327', 'briefTitle': 'A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apollo Endosurgery, Inc.'}, 'officialTitle': 'Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects', 'orgStudyIdInfo': {'id': 'IB-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIB®', 'description': 'Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.', 'interventionNames': ['Device: BioEnterics® Intragastric Balloon', 'Other: Behavioral modification']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Control arm receives the Behavioral modification intervention only.', 'interventionNames': ['Other: Behavioral modification']}], 'interventions': [{'name': 'BioEnterics® Intragastric Balloon', 'type': 'DEVICE', 'otherNames': ['BIB®'], 'description': 'Inflatable balloon inserted into the stomach.', 'armGroupLabels': ['BIB®']}, {'name': 'Behavioral modification', 'type': 'OTHER', 'description': 'Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise', 'armGroupLabels': ['BIB®', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Apollo Endosurgery', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Laura Eaton, RN, BSN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Apollo Endosurgery, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apollo Endosurgery, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}