Status: Not yet recruiting
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.
Participants needed: 100
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: GCA (Eurosilicone)Updated: Sep 25, 2026
Eligibility criteria
• Subjects aged ≥18 [+4]
Subjects with contra-indication to the surgery or not filling Instruction for Us...