Comparison of Mastectomy Expander Trial (NCT07434648) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Mastectomy Expander Trial
80 participantsStarted 2026-03-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use.
Timeframe: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Average trial duration per subject will be: 33,5 months; Duration of follow-up-phase is 2 years (FU1-12 months; FU2-24 months).
2
Aesthetic outcome assessment by Breast Aesthetic Scale and tissue analysis
Timeframe: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Average trial duration per subject will be: 33,5 months; Duration of follow-up-phase is 2 years (FU1-12 months; FU2-24 months).
Trial details
NCT IDNCT07434648
SponsorMedical University Innsbruck
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-12-31
Contact for this trial
Assoc. Prof. PD. Dr. Dolores Wolfram-Raunicher, MBA Department