Status:
RECRUITING
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
Lead Sponsor:
AWOgyn
Collaborating Sponsors:
Esculape GmbH
Conditions:
Implant Based Breast Reconstruction
Eligibility:
FEMALE
18+ years
Brief Summary
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 a...
Detailed Description
This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used...
Eligibility Criteria
Inclusion
- 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
- 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- Lack or withdrawn of written patients informed consent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.
Key Trial Info
Start Date :
November 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06511167
Start Date
November 8 2024
End Date
January 1 2029
Last Update
April 15 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
GRN-Klinik Weinheim
Weinheim, Baden-Wurttemberg, Germany, 69469
2
Klinik und Poliklinik für Frauenheilkunde Technische Universität München
München, Bavaria, Germany, 80337
3
Agaplesion Markus Krankenhaus Frankfurt
Frankfurt am Main, Hesse, Germany, 60431
4
Evangelisches Krankenhaus Wesel
Wesel, North Rhine-Westphalia, Germany, 46485