Reduction of Breast Enlargement Using the Da Vinci Xi Robot (R-HTM-R)

Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove.

The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.

Study Overview

• Status: Unknown
• Conditions: Breast Hypertrophy
• Intervention / Treatment: Procedure: Robot Breast reduction surgery

Detailed Description

Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloid scarring, especially in young women.

The current research project is based on the hypothesis that the same technique could be used in the context of a reduction of breast enlargement on a smaller surface allowing the determination of a perimammary "halo" of scar retraction. The project consists in removing a breast disc at the base, thus causing a sagging skin cut of 2 to 3 cm but this time, circular.

The expected result is to achieve a reduction in breast enlargement with no visible scar, using Da Vinci Xi robot.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean François OUDET; Phone Number: +33683346567; Email: jf.oudet@ecten.eu
• Study Contact Backup: Name: MH barba; Phone Number: +330664888704 +33664888704; Email: mh.barba@ecten.eu

Study Locations

• France
  • IDF
    • Antony, IDF, France, 92160
      • Recruiting
      • Hôpital Privé d'Antony
      • Contact: JF OUDET; Phone Number: +33683346567 +33683346567; Email: jf.oudet@ecten.eu
      • Contact: MH barba; Phone Number: +330664888704 +330664888704; Email: mh.barba@ecten.eu
      • Principal Investigator: Eric Dunet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women over the age of 18
• Category 1 or 2 according to the classification of Regnault
• Breast size cup c or more
• Areola "looking in front", ie a distance between point A (at noon at the top of the areola) at the mid-sternal point of about 16 cm to 24 cm
• Ptosis (distance between the lowest part of the breast and the furrow under the breast) to a maximum of 7cm (measurement in sitting position)
• Expected correction of ptosis by half with reduction of 1 to 3 cup sizes
• Good quality thick skin
• Affiliated patient or beneficiary of a social security scheme
• Patient requesting breast reduction
• Patient who signed free and informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot Reduction; The project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm .	Procedure: Robot Breast reduction surgery; Breast reduction surgery, using a robot by removing a breast disc at the base

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Visible Scare	The main judgment criterion for the scar balance will be a photograph of the breasts at 3 months to describe the number of visible scars. Aspect and position.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacity of the reduction (weight)	- The weight of the exeresis (more than 300g per side which corresponds according to calculation to a gland disc about 2 cm thick on an extended conical breast of 13cm for the base)	day of surgery
Intensity of Back Pain	The pain score on the EVA scale (score from 0 no pain to 10 max pain) will be described	3 months
Skin retraction	- Post-operative skin retraction	at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visible scare number	number of visible scare based on photos analysis	1 year

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Hôpital Privé d'Antony - Dr Dunet
• Investigators: Principal Investigator: Eric Dunet, Dr, Ramsay santé

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: breast reduction; perimammary
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: 2019-A01199-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No