Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT03570034
Status:
UNKNOWN
Last Update Posted:
2020-04-30
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Obalon Balloon System Post-Approval Study
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_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-03-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Event', 'timeFrame': '6-Month', 'description': 'Device or Procedure related Serious Adverse Event'}, {'measure': 'Percentage of Patients with at least 5% TBWL', 'timeFrame': '6-Month', 'description': 'Percentage of Patients with at least 5% TBWL'}, {'measure': 'Mean % TBWL', 'timeFrame': '6-Month', 'description': 'Mean %TBWL'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.', 'detailedDescription': 'The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients aged 22 years and older, who are considered obesity Class I or II with a BMI of 30.0-40.0 kg/m2; and, have failed to lose weight through diet and exercise\n* Patients willing to commercially purchase the device.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 22 years old\n* BMI of 30-40 kg/m2\n\nExclusion Criteria:\n\n* Contraindicated for the device\n* Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.\n* Known history of endocrine disorders affecting weight.\n* Participation in any clinical study which could affect weight loss within the past year\n* Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus\n* Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT03570034', 'acronym': 'PAS', 'briefTitle': 'Obalon Balloon System Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Obalon Therapeutics, Inc.'}, 'officialTitle': 'Obalon Balloon System - Post-Approval Study', 'orgStudyIdInfo': {'id': 'PTL-7500-0011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obalon Balloon System', 'description': 'Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program', 'interventionNames': ['Device: Obalon Balloon System']}], 'interventions': [{'name': 'Obalon Balloon System', 'type': 'DEVICE', 'description': 'Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program', 'armGroupLabels': ['Obalon Balloon System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92694', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Smart Dimensions Weight Loss', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '91202', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Davtyan Medical Weight Loss and Wellness', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Lifetime Surgical Weight Loss', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'SkyLex Health', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Surgical Specialists of Louisiana', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '07081', 'city': 'Springfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Bariatric Center', 'geoPoint': {'lat': 40.70491, 'lon': -74.31723}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Greenwich Village Gastroenterology', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '11577', 'city': 'Roslyn Heights', 'state': 'New York', 'country': 'United States', 'facility': 'New York Bariatric Group', 'geoPoint': {'lat': 40.78871, 'lon': -73.64735}}, {'zip': '45241', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'JourneyLite Physicians', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Artisan Cosmetic Surgery', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Minimally Invasive Surgical Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75028', 'city': 'Flower Mound', 'state': 'Texas', 'country': 'United States', 'facility': 'Snow Bariatic Center', 'geoPoint': {'lat': 33.01457, 'lon': -97.09696}}, {'zip': '76102', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ultimate Bariatrics', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Bariatric Medical Institute of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Shelby Sullivan, MD, FACG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Rachel Moore, MD, FACS, FASMBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical Specialist of Louisiana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obalon Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}