NCT07434648 Comparison of Mastectomy Expander Trial
| NCT ID | NCT07434648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Mastectomy and Breast Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-04-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Dolores Wolfram-Raunicher, MBA Department, Assoc. Prof. PD. Dr. med. univ
✉ dolores.wolfram@i-med.ac.at📞 43/512/504/82050
Frequently Asked Questions
Who can join the NCT07434648 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Mastectomy and Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07434648 currently recruiting?
Yes, NCT07434648 is actively recruiting participants. Contact the research team at dolores.wolfram@i-med.ac.at for enrollment information.
Where is the NCT07434648 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT07434648 clinical trial?
NCT07434648 is sponsored by Medical University Innsbruck. The trial plans to enroll 80 participants.