Comparison of Mastectomy Expander Trial

Starting soon · Not applicable

Conditions studied: Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction, Adjuvant Radiotherapy, Long Term Outcome

In brief

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).

Key facts

Study ID

NCT07434648

Run by

Medical University Innsbruck

People needed

80

Starts

2026-03-01

Expected to finish

2031-12-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Understands and agrees to comply with the study procedures and provides informed consent as documented by signature
• Female subjects aged ≥ 18 years at time of consent
• INDICATION: Breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy OR ductal carcinoma in situ (DCIS) diagnosis without neoadjuvant chemotherapy AND / OR positive genetic counseling for high-risk family history of breast cancer
• RECONSTRUCTION MODALITIES: planned uni- or bilateral NSME or SSME with simultaneous prepectoral tissue expander-based breast reconstruction due to malignancy OR Planned prophylactic bilateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction. Planned unilateral NSME or SSME and planned prophylactic contralateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction
• Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said or written.
• Inclusion criterion 6 only applies to subject with radiotherapy: Adjuvant radiotherapy as part of the breast cancer treatment plan
• Inclusion criterion 7 only applies to women of childbearing potential (WOCBP): negative urine pregnancy test, not breastfeeding

You may not qualify if…

• Subject with implanted device that may be affected by magnetic fields (pacemaker)
• Known presence of HIV, viral hepatitis (patient-reported)
• Presence of autoimmune disease(s) or immunocompromised subject due to immunosuppressive or steroid therapy
• The subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study.

Full record on ClinicalTrials.gov

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