Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 6:24 PM
Study NCT ID:
NCT01249950
Status:
TERMINATED
Last Update Posted:
2013-11-11
First Post:
2010-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Appropriateness of Bariatric Surgery in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D005240', 'term': 'Feasibility Studies'}], 'ancestors': [{'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-08', 'studyFirstSubmitDate': '2010-11-26', 'studyFirstSubmitQcDate': '2010-11-26', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'potential number of patients eligible for surgery', 'timeFrame': '24 months', 'description': 'evaluate prospectively the potential number of patients eligible for surgery, among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Morbid obesity', 'teenagers', 'co-morbidities', 'bariatric surgery', 'epidemiology'], 'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.', 'detailedDescription': 'This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adolescents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* failure of weight loss in an organized care\\> 6 months\n* BMI \\> à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI \\> or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.\n* Patients must have completed their growth (bone age \\> 13 for girls and \\>15 for boys).\n* The teenager and his legal representative must have given their informed consent.\n* The subject must be affiliated to a social security scheme\n\nExclusion Criteria:\n\n* syndromic obesities\n* tumor-induced obesity\n* Patient with severe psychiatric disorders\n* Patient with eating disorders\n* Patients under judicial protection\n* Patient under guardianship or curatorship\n* Patient participating in another study'}, 'identificationModule': {'nctId': 'NCT01249950', 'briefTitle': 'Study on the Appropriateness of Bariatric Surgery in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Study on the Appropriateness of Bariatric Surgery in Adolescents', 'orgStudyIdInfo': {'id': '08 157 02'}, 'secondaryIdInfos': [{'id': '2008-A01320-55', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'adolescents', 'description': 'adolescents with morbid obesity', 'interventionNames': ['Other: feasibility']}], 'interventions': [{'name': 'feasibility', 'type': 'OTHER', 'description': 'feasibility', 'armGroupLabels': ['adolescents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'UHToulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Béatrice JOURET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}