Volumetric Study of the Buttocks After Flap Augmentation... | NCT03777618

Studies
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

NCT03777618

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Weight Loss

Interventions

gluteal augmentation with flap in circumferential body lift

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Oct 15, 2019Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Sep 28, 2018

First Submission Date that Met QC Criteria

Dec 14, 2018

First Posted Date

Dec 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gluteal augmentation with flap in circumferential body lift	Procedure	classic circumferential bodylift surgery, using two differents well-known flaps for gluteal augmentation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluate gluteal volume	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	1 day

Secondary Outcomes

Measure	Description	Time Frame
Surgical complication	Surgical complication during hospitalization, then 15 days after the operation and 1 month after the operation	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

12 months minimum delay with bariatric surgery
female, BMI<30kg/m2
Age greater than or equal to 18 years
Stable weight for more than 6 months
lack of volume in gluetal region
agree with clinical trial

Exclusion criteria:

Patient under tutorship or curatorship
Pregnancy or breastfeeding
hemoglobinemia< 12g/dL
Albuminemia<3,5g/dL
active smoking more than 1 month before surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Farid BEKARA, MD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013524	Surgical Flaps
D000073880	Body Contouring

Ancestor Terms

ID	Term
D019738	Surgically-Created Structures
D004864	Equipment and Supplies
D003357	Cosmetic Techniques
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided