NCT03715738: MENABREA

MEasurement by a Numerical Approach of BREAst Volume

Completed NA Last updated 30 December 2024

What this trial tests

NA trial testing arm 1 : Creaform3D + MyotonPRO in Breast Asymmetry, 3D in 30 participants. Completed in 18 September 2023.

Timeline

2 July 2019

Primary endpoint
18 April 2023

18 September 2023

Quick facts

Lead sponsor	University Hospital, Angers
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	2 July 2019
Primary completion	18 April 2023
Estimated completion	18 September 2023
Sites	1 location across France

Drugs / interventions tested

• arm 1 : Creaform3D + MyotonPRO

Conditions studied

• Breast Asymmetry, 3D — all drugs for Breast Asymmetry, 3D →

Sponsor

University Hospital, Angers

Who can join

18 and older, female only, with Breast Asymmetry, 3D. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Breast asymmetry is a rare in plastic surgery. In majority of cases, it is idiopathic.

In cases that are poorly tolerated physically (vertebral imbalance, posture disorders) or psychologically, the decision to perform breast symmetrization surgery can be made. It is recommended to do this surgery after a slimming treatment if the woman is overweight or after pregnancy that causes a change in the structure and volume of the chest. In fact, the weight variations deteriorate the long-term result.

However, this surgical management remains difficult. In fact, the volume to be removed (unilateral breast reduction) to be symmetrized is a function of the volume of the contralateral breast and the preoperative drawings are made while standing. Currently, the evaluation of the volume to be removed remains subjective and is based on the experience of the surgeon. In addition, intraoperatively, this evaluation is also subjective because the patient is lying down which changes the position of the anatomical landmarks: the optimization of the symmetrization is only possible by the eye and the touch.

No measuring device is currently used to assess the difference in volume between the 2 breasts and guide the surgeon in the volume (or weight) to remove. It is therefore sometimes necessary to perform a second intervention in case of residual postoperative asymmetry.

Primary objective :

To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO).

Second objective : To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.