Reduction of Breast Enlargement Using the Da Vinci Xi Robot

Breast Hypertrophy Clinical Trial

— R-HTM-R  

Official title:

Reduction of Breast Enlargement Using the Da Vinci Xi Robot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597515
• Other study ID #: 2019-A01199-48
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2020
• Source: Ramsay Générale de Santé
• Contact: Jean François OUDET
• Phone: +33683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Hypertrophy
• Hypertrophy

Intervention

Procedure:
• Robot Breast reduction surgery
Breast reduction surgery, using a robot by removing a breast disc at the base

Locations

Country	Name	City	State
France	Hôpital Privé d'Antony	Antony	IDF

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Hôpital Privé d'Antony - Dr Dunet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visible scare number	number of visible scare based on photos analysis	1 year
Primary	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	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
Secondary	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
Secondary	Skin retraction	- Post-operative skin retraction	at 3 months