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ACTIVE NOT RECRUITING
NCT07904091

Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years

Sponsor: Laboratoires ARION

View on ClinicalTrials.gov

Summary

The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at 10 years. The primary objective is to evaluate the rate of women who had at least one re-intervention within the 10 years of follow-up. the secondary objectives are To evaluate the safety and performance outcomes of women who underwent breast augmentation and/or breast reconstruction using the Monobloc® - Silicone SoftOne® breast implants at 10 years Participants will have one follow-up visit during which data will be retrospectively documented at the following time points: preoperative visit, operative visit, follow-up 10 years

Official title: Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years: Post-marketing Clinical Follow-up Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

630

Start Date

2023-09-07

Completion Date

2027-01-07

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DEVICE

Breast augmentation

Breast augmentation with implants

DEVICE

Breast reconstruction

Breast reconstruction with implants

Locations (5)

Academia Aesthetica

Bordeaux, France

Cabinet de chirurgie esthétique de Marseille

Marseille, France

Cabinet de chirurgie esthétique de Paris

Paris, France

Cabinet Médical Esthétique Paris 7

Paris, France

CHU de Toulouse

Toulouse, France