Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-04 @ 11:18 PM
Study NCT ID:
NCT03777618
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2018-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013524', 'term': 'Surgical Flaps'}, {'id': 'D000073880', 'term': 'Body Contouring'}], 'ancestors': [{'id': 'D019738', 'term': 'Surgically-Created Structures'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate gluteal volume', 'timeFrame': '1 day', 'description': 'evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera between the preoperative and at 2 months after surgery and 3 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Surgical complication', 'timeFrame': '1 day', 'description': 'Surgical complication during hospitalization, then 15 days after the operation and 1 month after the operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plastic and reconstructive surgery', 'gluteal ptosis', 'platipygia'], 'conditions': ['Weight Loss']}, 'descriptionModule': {'briefSummary': 'The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 12 months minimum delay with bariatric surgery\n* female, BMI\\<30kg/m2\n* Age greater than or equal to 18 years\n* Stable weight for more than 6 months\n* lack of volume in gluetal region\n* agree with clinical trial\n\nExclusion criteria:\n\n* Patient under tutorship or curatorship\n* Pregnancy or breastfeeding\n* hemoglobinemia\\< 12g/dL\n* Albuminemia\\<3,5g/dL\n* active smoking more than 1 month before surgery'}, 'identificationModule': {'nctId': 'NCT03777618', 'briefTitle': 'Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential Body Lift', 'orgStudyIdInfo': {'id': 'RECHMPL18_0239'}}, 'armsInterventionsModule': {'interventions': [{'name': 'gluteal augmentation with flap in circumferential body lift', 'type': 'PROCEDURE', 'description': 'classic circumferential bodylift surgery, using two differents well-known flaps for gluteal augmentation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Farid BEKARA, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}