Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-06 @ 12:27 AM
Study NCT ID:
NCT00570505
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2007-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.eaton@apolloendo.com', 'phone': '949-468-9301', 'title': 'Laura Eaton', 'organization': 'Apollo Endosurgery'}, 'certainAgreement': {'otherDetails': 'The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'LapBand', 'description': 'Subjects implanted with the LapBand(R) Adjustable Gastric Band System', 'otherNumAtRisk': 149, 'otherNumAffected': 145, 'seriousNumAtRisk': 149, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 104, 'numAffected': 104}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 73, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 77, 'numAffected': 77}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric dilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Regurgitation of food', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Esophageal dilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Implant site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Abdominal cavity abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Band erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric outlet obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Esophageal spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Umbilical hernia contained LAP-BAND tubing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Recurrent gastric stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Band slip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hiatal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pouch dilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Esophageal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One year', 'description': 'The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Percent Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'categories': [{'measurements': [{'value': '18.32', 'spread': '8.516', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 12 months', 'description': 'Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.', 'unitOfMeasure': 'percentage of weight loss', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Change in Comorbid Conditions Related to Obesity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'title': 'Diabetes Type II (n = 6)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Dyslipidemia (n = 29)', 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension (n = 27)', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as "none" on a severity scale of none, mild, moderate, or severe) 12 months after implantation.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27)'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'categories': [{'measurements': [{'value': '28.03', 'spread': '17.274', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}, {'type': 'POST_HOC', 'title': 'Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '67.75', 'upperLimit': '84.43'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'The percent of subjects who attained clinically successful weight loss (ie, ≥ 30% Excess Weight Loss) at year 5 post LAP-BAND implantation. Percent EWL =(weight loss divided by excess weight)\\*100. Excess Weight was defined as Baseline Weight - Ideal Weight, where Ideal Weight was a BMI of 25 kg/m2.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}, {'type': 'POST_HOC', 'title': 'Subject Percent Excess Weight Loss (5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'categories': [{'measurements': [{'value': '62.74', 'spread': '41.131', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)\\*100.', 'unitOfMeasure': 'percentage of excess weight loss', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}, {'type': 'POST_HOC', 'title': 'Change in Obesity Related Comorbid Conditions (5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'title': 'Type 2 Diabetes (n=5)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Dyslipidemia (n=45)', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension (n=49)', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved 5 years post LAP-BAND implantation. Diabetes resolution was defined as HbA1c ≤ 6% and no diabetes medication usage. Dyslipidemia resolution was defined as HDL ≥ 60 mg/dL, LDL \\< 100 mg/dL, triglycerides \\< 150 mg/dL, and total cholesterol \\< 200 mg/dL. Hypertension resolution was defined as systolic blood pressure \\< 140 mm Hg.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49)'}, {'type': 'POST_HOC', 'title': 'Change in Quality of Life (5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'classes': [{'categories': [{'measurements': [{'value': '29.23', 'spread': '19.397', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 5 years in IWQOL-Lite Total Score is reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.\n\nLAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The number of subjects completing the 60-month study', 'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Other loss to follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '155 Subjects were enrolled per protocol (defined as signing the informed consent). After enrollment, 4 subjects withdrew consent prior to treatment, and 2 subjects were not implanted due to ineligibility discovered during screening. This resulted in 149 subjects starting the study and receiving treatment with the LAP-BAND System.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LapBand', 'description': 'Subjects implanted with the LapBand(R) Adjustable Gastric Band System'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '147', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.28', 'spread': '9.304', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2007-12-10', 'resultsFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-02', 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation', 'timeFrame': 'One year', 'description': 'The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.'}], 'secondaryOutcomes': [{'measure': 'Percent Weight Loss', 'timeFrame': 'Baseline through 12 months', 'description': 'Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.'}, {'measure': 'Change in Comorbid Conditions Related to Obesity', 'timeFrame': '12 months', 'description': 'Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as "none" on a severity scale of none, mild, moderate, or severe) 12 months after implantation.'}, {'measure': 'Change in Quality of Life', 'timeFrame': '12 months', 'description': 'Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23637029', 'type': 'RESULT', 'citation': 'Michaelson R, Murphy DK, Gross TM, Whitcup SM; LAP-BAND Lower BMI Study Group. LAP-BAND for lower BMI: 2-year results from the multicenter pivotal study. Obesity (Silver Spring). 2013 Jun;21(6):1148-58. doi: 10.1002/oby.20477.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \\< 40 kg/m2.', 'detailedDescription': 'LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \\< 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a BMI ≥ 30 kg/m2 and \\< 35 kg/m2 (with or without comorbid conditions) or a BMI ≥ 35 kg/m2 and \\< 40 kg/m2 without severe comorbid conditions\n* Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs\n\nExclusion Criteria:\n\n* Subject history of congenital or acquired anomalies of the gastrointestinal tract\n* Severe cardiopulmonary or other serious or uncontrolled organic disease\n* Severe coagulopathy; hepatic insufficiency or cirrhosis\n* History of bariatric; gastric; or esophageal surgery\n* History of intestinal obstruction or adhesive peritonitis\n* History of esophageal dysmotility disorders\n* Type I diabetes'}, 'identificationModule': {'nctId': 'NCT00570505', 'briefTitle': 'Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apollo Endosurgery, Inc.'}, 'orgStudyIdInfo': {'id': 'LBMI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LapBand', 'description': 'All subjects who receive the LAP-BAND System.', 'interventionNames': ['Device: LAP-BAND System']}], 'interventions': [{'name': 'LAP-BAND System', 'type': 'DEVICE', 'description': 'Reduction of food intake due to creation of smaller stomach pouch', 'armGroupLabels': ['LapBand']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apollo Endosurgery, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}