Actively Recruiting
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
Led by AWOgyn · Updated on 2026-05-11
135
Participants Needed
5
Research Sites
216 weeks
Total Duration
On this page
Sponsors
A
AWOgyn
Lead Sponsor
E
Esculape GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with confirmed breast cancer, precancerous conditions, genetic risk, or family history with indication for skin sparing or nipple sparing mastectomy, or prophylactic operation
- ECOG performance status 0 to 2
- Decision to use TIGR4 Matrix made before and independent of study enrollment
- Mentally able to understand the study's nature, aims, and possible consequences
- Provided signed informed consent
- At least 18 years old
You will not qualify if you...
- Pregnancy or breastfeeding
- Known intolerance to the TIGR4 Matrix or similar mesh implants
- Metastatic breast cancer with life expectancy less than 5 years
- Poorly controlled diabetes
- Low bone marrow function with neutrophil granulocytes below 1500 and platelets below 100,000/�b5l
- Withdrawal or lack of written informed consent
- Non-compliance with data collection, treatment, or follow-up
- Institutionalized by court or official order
- Participation in another surgical clinical trial affecting surgical technique or outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
GRN-Klinik Weinheim
Weinheim, Baden-Wurttemberg, Germany, 69469
Active, Not Recruiting
2
Klinik und Poliklinik für Frauenheilkunde Technische Universität München
München, Bavaria, Germany, 80337
Actively Recruiting
3
Agaplesion Markus Krankenhaus Frankfurt
Frankfurt am Main, Hesse, Germany, 60431
Actively Recruiting
4
Evangelisches Krankenhaus Wesel
Wesel, North Rhine-Westphalia, Germany, 46485
Actively Recruiting
5
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany, 06110
Actively Recruiting
Research Team
M
Marc Thill, Prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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