A Clinical Study Evaluating the Safety and Performance of Eurosilicone Integrated Valve Tissue Expanders (IVTE)

September 21, 2026 updated by: GCA (Eurosilicone)

A Retrospective, Multi-center, Observational, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone IVTE Range of Silicone Breast Expanders When Used for Breast Reconstruction.

Patients can undergo breast reconstruction surgery in two stages before implantation of the permanent prosthesis for several reasons. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants.

This study is designed to collect data on Integrated valve tissue expander to assess the performance and safety data on this device.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Device: Breast reconstruction surgery

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women over 18 years old who underwent a two-stage breast reconstruction with Eurosilicone integrated valve tissue expander.

Description

Inclusion Criteria:

• Subjects aged ≥18
- Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:
  - Reconstruction of the breast following subcutaneous mastectomy and other mastectomy procedures or trauma.
  - Breast underdevelopment and combined breast and chest wall abnormalities.
  - Scar/defect revision
- Subjects who have received a Eurosilicone IVTE.

Exclusion Criteria:

Subjects with contra-indication to the surgery or not filling Instruction for Use (IFU) indications, contra-indications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: RETROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of reconstruction failure Time Frame: 2 years after the tissue expander implantation surgery	Reconstruction failure means that the definitive reconstructive surgery (breast implant or autologous reconstruction) either did not take place or was unsuccessful.	2 years after the tissue expander implantation surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCA (Eurosilicone)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)