Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
Recruiting now
Conditions studied: Implant Based Breast Reconstruction
In brief
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.
Key facts
- Study ID
- NCT06511167
- Run by
- AWOgyn
- People needed
- 135
- Starts
- 2024-11-08
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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- Lack or withdrawn of written patients informed consent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.
Where it is running
- Klinik und Poliklinik für Frauenheilkunde Technische Universität München — München, Bavaria, Germany (enrolling)
- Agaplesion Markus Krankenhaus Frankfurt — Frankfurt am Main, Hesse, Germany (enrolling)
- Evangelisches Krankenhaus Wesel — Wesel, North Rhine-Westphalia, Germany (enrolling)
- Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH — Halle, Germany (enrolling)
- GRN-Klinik Weinheim — Weinheim, Baden-Wurttemberg, Germany
Full record on ClinicalTrials.gov
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