Actively Recruiting
National, Prospective, Multicentre Post Market Surveillance Study on Patient Reported Outcome of Implant Based Reconstructive Breast Surgery Using the Complete Resorbable Synthetic TIGR ae Matrix
Led by AWOgyn · Updated on 2026-05-11
135
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AWOgyn
Lead Sponsor
E
Esculape GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the quality of life and safety of the fully resorbable TIGR ae Matrix in women who have undergone implant-based breast reconstruction surgery after mastectomy. This observational, national, multicenter, prospective study aims to collect data on patient-reported outcomes and complications related to this surgical mesh device. Participants will have had the TIGR ae Matrix used during their breast reconstruction either as primary or secondary surgery. The study monitors quality of life using the BREAST-Q questionnaire at multiple time points after surgery, including 6, 12, 24, and 36 months. It also tracks complication rates, hospital stay duration, cosmetic outcomes, and any unplanned additional surgeries over three to five years. During the study, participants will complete questionnaires about their quality of life and undergo follow-up assessments to document complications and cosmetic results. Researchers will observe outcomes for up to five years after surgery. The primary focus is on quality of life measured 12 months post-surgery, with additional long-term monitoring to ensure safety and effectiveness of the device.
CONDITIONS
Brief 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 risks, or family history indicating skin sparing or nipple sparing mastectomy, or requiring prophylactic surgery
- Good health status with ECOG performance 0-2
- Decision to use TIGR�ae Matrix made before and independent of study enrollment
- Mentally able to understand the study's nature, aims, and possible consequences
- Provided informed consent
- Aged 18 years or older
You will not qualify if you...
- Pregnant or breastfeeding women
- Known intolerance to TIGR�ae Matrix or similar mesh implants
- Metastatic breast cancer with less than 5 years life expectancy
- Poorly controlled diabetes
- Inadequate bone marrow function with low neutrophils or platelets
- Withdrawal or lack of informed consent
- Lack of compliance with data collection or follow-up
- Institutionalized by court order
- Participation in other surgical clinical studies affecting surgical technique or outcome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From surgery to hospital discharge
Participants undergo implant-based reconstructive breast surgery using the TIGR® Matrix with monitoring of hospital stay and days with drains.
Hospital stay duration with monitoring during stay
Duration - Up to 5 years after surgery
Participants have follow-up visits to assess quality of life, cosmetic outcome, and complication rates after surgery.
Visits at 6, 12, 24, 36 months and additional monitoring for complications up to 5 years
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.
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here