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

N/ANot Yet RecruitingNCT07842406

GCA (Eurosilicone)100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Reconstruction Mammary Reconstruction

Interventions

Breast reconstruction surgeryDEVICE

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

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 2 years after the tissue expander implantation surgery

Data from ClinicalTrials.gov

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