MedTrace Logo

Comparison of Mastectomy Expander Trial

NCT07434648 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-25

No results posted yet for this study

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).

Conditions

  • Mastectomy and Breast Reconstruction
  • Tissue Expander Based Breast Reconstruction
  • Adjuvant Radiotherapy
  • Long Term Outcome

Interventions

RADIATION

intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy

Patients who are scheduled for tissue expander-based breast reconstruction will be randomized in one of two expander groups (Arm 1= Motiva Flora® Tissue Expander \& Arm 2 = SILTEX™ BECKER™ expander). Subjects, who are routinely scheduled for radiotherapy (collective I) will subsequently undergo two additional visits. Subjects without scheduled radiotherapy (collective II), will continue without additional visits - unless they need to change their collective for therapeutic reasons. Assesments: 1. efficacy and safety of therapeutic and prophylactic comparative tissue expander-based breast reconstruction 2. structural and functional changes in comparative tissue expanders following exposure to radiotherapy vs. non-radiotherapy

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-31
Completion
2031-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07434648 on ClinicalTrials.gov