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Breast reconstruction study tests expanders beyond approved use

NCT ID NCT07434648

Knowledge-focused Sponsor: Medical University Innsbruck Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare two different tissue expanders used in breast reconstruction after mastectomy in 80 women. Some participants will also receive radiation therapy, which is not typically recommended with these devices. Researchers will evaluate aesthetic outcomes, patient satisfaction, complications, and how radiation affects the expander material and surrounding tissue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tissue expander (Motiva Flora or SILTEX BECKER)
What this could lead to
If successful, this study could help doctors choose the best expander for breast reconstruction and understand how radiation affects the implant material and surrounding tissue.
What could go wrong
This is an early exploratory study with only 80 participants, so results may not apply to everyone. Using expanders beyond their approved duration or with radiation carries unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer ductal breast carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adjuvant radiotherapy Long-term outcome Mastectomy and breast reconstruction Tissue expander based breast reconstruction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.