CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Prophylactic mastectomy with immediate breast reconstructionprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03838549
NCT03838549N/ACompleted

Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

University Hospital, Montpellier·interventional·Posted Feb 12, 2019·Updated Apr 24, 2026

In Brief

A clinical study evaluating Prophylactic mastectomy with immediate breast reconstruction for Genetic Predisposition and Breast Cancer. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 12, 2019
Enrollment StartApr 26, 2019
Primary CompletionSep 26, 2025
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 7.4 years ago

Interventions

Prophylactic mastectomy with immediate breast reconstructionprocedure

It is an endoscopic approach for prophylactic mastectomy using an axillary single port