Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07842406

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Reconstruction Mammary Reconstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast reconstruction surgery

Device

The tissue expander is inserted during the first surgery and expanded with sterile solution. After 6 months (or less), the tissue expander is removed and the brest implant is inserted during the second surgery.

Primary outcomes

  1. 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.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

GCA (Eurosilicone)

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.