Clinical Trial

Comparison of Mastectomy Expander Trial

Study acronym: COMMET
Not Yet Recruiting
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Summary
Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy/expander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer. Requested answers: * how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment, * how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants, * how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material, * which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).
Trial Details
NCT Number NCT07434648
Lead Sponsor Medical University Innsbruck
Conditions Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction, Adjuvant Radiotherapy, Long Term Outcome
Enrollment 80 participants
Start Date 2026-03-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-25