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A Clinical Study Evaluating the Safety and Performance of Eurosilicone Integrated Valve Tissue Expanders (IVTE)
Sponsor: GCA (Eurosilicone)
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.
Official 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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-10
Completion Date
2027-10
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
Breast reconstruction surgery
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.