Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New dissolvable mesh for breast reconstruction under study

NCT ID NCT06511167

Symptom relief Sponsor: AWOgyn Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 135 women who have had breast reconstruction after mastectomy using a special dissolvable mesh called TIGR® Matrix. The goal is to see how the mesh affects their quality of life over three years. Participants will fill out a questionnaire about their symptoms and daily activities. The study is observational, meaning it just watches what happens without changing treatment.

What this could mean

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

Active substance
TIGR® Matrix (bioresorbable surgical mesh)
What this could lead to
If successful, this could confirm that the TIGR® Matrix is a safe and effective option for breast reconstruction, improving patient quality of life.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Complications like infection or mesh issues are possible.

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.

Participants

About 135 people

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

Started

Nov 2024

Expected to finish

Jan 2029

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.

Who is studied

Women who will undergo breast prepectoral implant-based breast reconstructive surgery

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: * Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation * The health of women must comply with ECOG performance status 0-2 * The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment * Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation * Patient information has been handed out and subject signed informed consent * Participant has attained full age of 18 years Exclusion Criteria: * Pregnancy or breast-feeding patients * Known intolerance to the material, mesh-implants under investigation * Metastatic breast cancer (with a life expectancy \< 5 years) * Medicinal dis-regulated diabetes * Inadequate bone marrow function with neutrophil granulocytes\<1500 and blood plates \< 100.000/µl * Lack or withdrawn of written patients informed consent * Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol * Participant is institutionalized by court or official order (MPDG §27) * Participation in another surgical clinical investigation that influence the surgical technique or outcome.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer precancerous condition

As listed by the trial registrant

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

Implant based breast reconstruction

How to take part

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

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Agaplesion Markus Krankenhaus Frankfurt

    RECRUITING

    Frankfurt am Main, Hesse, 60431, Germany

  • Evangelisches Krankenhaus Wesel

    RECRUITING

    Wesel, North Rhine-Westphalia, 46485, Germany

  • GRN-Klinik Weinheim

    ACTIVE_NOT_RECRUITING

    Weinheim, Baden-Wurttemberg, 69469, Germany

  • Klinik und Poliklinik für Frauenheilkunde Technische Universität München

    RECRUITING

    München, Bavaria, 80337, Germany

  • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

    RECRUITING

    Halle, 06110, Germany

More trials for these conditions

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