Reduction of Breast Hypertrophy by Means of Coelioscopiqu... | NCT05822115

Studies
Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

NCT05822115

Sponsor

Groupe Hospitalier Nord-Essonne

Status

Unknown status

Last Update Posted

May 9, 2023Actual

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Breast Reduction

Interventions

Reduction of breast hypertrophy by means of laparoscopic

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2023Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Mar 21, 2023

First Submission Date that Met QC Criteria

Apr 7, 2023

First Posted Date

Apr 20, 2023Actual

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

May 5, 2023

Last Update Posted Date

May 9, 2023Actual

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 objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy.

This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.

Detailed Description

Breast reductions are common procedures. One of the main difficulties related to this surgery remains the healing, wide at the peri-areolar level, vertical at the sub-areolar level and in the sub-mammary fold. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloidal healing, especially in young subjects.

On This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result without scarring in the context of the reduction of medium volume breast hypertrophy.

Ultimately, the results of this study may serve as a basis for further research by proposing:

Prophylactic mastectomies and immediate breast reconstruction without lateral scar and with a less visible sub-breast scar.
A breast reduction in young patients before the skin undergoes the effects of the heaviness of the breasts.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treated group	Experimental	Breast reduction	Device: Reduction of breast hypertrophy by means of laparoscopic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reduction of breast hypertrophy by means of laparoscopic	Device	The research procedure is a breast reduction performed by means of laparoscopic surgery. The project consists of removing a disc from the breast at the level of the base, thus causing peripheral skin slackening of 2 to 3 cm but circular. Both breasts are usually operated on at the same time. In case of asymmetry, only one side will be treated.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Photography of the scar	centimeter	at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Scar assessment	number of scars	at 3 weeks
Resection weight	Resection weight	at 0 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

Women over the age of 18.
Category 1 or 2 according to the Regnault classification.
C cup breast size or larger.
Areola "looks ahead" i.e. a distance between point A (at the top of the areola) at the median suprasternal point of approximately 16 cm to 24 cm.
Ptosis (distance between the lowest part of the breast and the submammary fold) of a maximum of 7cm (measured in a seated position).
Expected correction of half ptosis with decrease of 1 to 3 cup sizes.
Patient has good quality thick skin.
Social security scheme.
Patient requesting breast reduction.
Patient having signed the free and informed consent.

Non inclusion criteria :

Areola "look down"; point A more than 25 cm.
Ptosis greater than or equal to 8 cm.
Thin skin.
Smoker.
Patient under effects of anti-coagulant.
Patient participating in another clinical study.
Protected patient: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Pregnant, lactating woman.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eric Dr DUNET, Chirurgien	Contact	+33607812501		ericdunet@gmail.com
Jérôme Mr KOZLOWSKI, Directeur Innovation Recherche	Contact	+33664542963		n.goumas@ghne.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr Eric DUNET	Recruiting	Longjumeau		91160	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided