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

NCT07842406 | Not Yet Recruiting

• 1 other identifier: CLA-0024
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Reconstruction; Mammary Reconstruction

Outcome Measures

Primary Outcomes (1)

• Rate of reconstruction failure

  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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GCA (Eurosilicone): lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09