Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT01288456
Status:
COMPLETED
Last Update Posted:
2012-05-28
First Post:
2011-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Novel Gastric Space Occupying Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-25', 'studyFirstSubmitDate': '2011-01-31', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medical device, space-occupying device'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be selected from a community sample that satisfy the inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 21-64 years\n2. BMI 27-40 Kg/m2\n3. No history of weight reduction of more than 5% of total body weight in the past 6 months\n\nExclusion Criteria:\n\n1. Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;\n2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;\n3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;\n4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;\n5. History or symptoms of thyroid disease which is not controlled by medication;\n6. Have severe renal, hepatic, pulmonary disease or cancer;\n7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);\n8. Have a history of adhesive peritonitis;\n9. History or symptoms of esophageal and/or gastric varices;\n10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);\n11. History or symptoms of inflammatory bowel disease, such as Chron's disease;\n12. History of/ signs and /or symptoms of duodenal or gastric ulcer;\n13. Have gastroparesis;\n14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);\n15. Currently using pharmaceutical agents for weight loss;"}, 'identificationModule': {'nctId': 'NCT01288456', 'briefTitle': 'Study to Evaluate Novel Gastric Space Occupying Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Obalon Therapeutics, Inc.'}, 'officialTitle': 'A Single Centre 30-day Observational Non-randomised Study to Evaluate Preliminary Safety and Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss', 'orgStudyIdInfo': {'id': 'PTL-1000-0005'}}, 'contactsLocationsModule': {'locations': [{'city': 'Tijuana', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Obesity Control Center', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}], 'overallOfficials': [{'name': 'Ariel Ortiz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obesity Control Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obalon Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}