Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-21 @ 12:30 AM
Study NCT ID:
NCT03688256
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obalon US Commercial Registry
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1343}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-26', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Outcome - Serious Adverse Events', 'timeFrame': '6 months', 'description': 'Percentage of Patients with Serious Adverse Events'}, {'measure': 'Primary Effectiveness Outcome - Weight Loss Metrics', 'timeFrame': '6 months', 'description': 'Mean Weight Loss Metrics'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Retrospective study of the data reported in the Obalon US Commercial Registry', 'detailedDescription': 'Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obalon Commercial Patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Started Obalon Balloon Therapy between Jan.-Dec. 2017\n* Weight loss data through balloon removal\n* BMI \\>25kg/m2'}, 'identificationModule': {'nctId': 'NCT03688256', 'briefTitle': 'Obalon US Commercial Registry', 'organization': {'class': 'OTHER', 'fullName': 'Surgical Specialists of Louisiana'}, 'officialTitle': 'Obalon Balloon System: Real-World Evidence Commercial Site Registry', 'orgStudyIdInfo': {'id': '01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Obalon Balloon System', 'type': 'DEVICE', 'description': '6 month Obalon Intragastric Balloons'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Surgical Specialists of Louisiana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Obalon Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}