A Clinical Study Evaluating the Safety and Performance of Eurosilicone Integrated Valve Tissue Expanders (IVTE)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorGCA (Eurosilicone)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Subjects aged ≥18
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
Disqualifiers
Subjects with contra-indication to the surgery or not filling Instruction for Use (IFU) indications, contra-indications.
Trial population
Women over 18 years old who underwent a two-stage breast reconstruction with Eurosilicone integrated valve tissue expander.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Breast reconstruction surgery
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
2 years after the tissue expander implantation surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: