Clinical Research Directory
Browse clinical research sites, groups, and studies.
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
Sponsor: AWOgyn
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 also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.
Official title: National, Prospective, Multicentre Post Market Surveillance Study on "Patient Reported Outcome" of Implant Based Primary or Secondary Reconstructive Breast Surgery After Mastectomy Using the Complete Resorbable Synthetic TIGR® Matrix
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
135
Start Date
2024-11-08
Completion Date
2029-01
Last Updated
2025-04-15
Healthy Volunteers
No
Conditions
Interventions
TIGR® Matrix
bioresorbable, synthetic, surgical mesh
Locations (5)
GRN-Klinik Weinheim
Weinheim, Baden-Wurttemberg, Germany
Klinik und Poliklinik für Frauenheilkunde Technische Universität München
München, Bavaria, Germany
Agaplesion Markus Krankenhaus Frankfurt
Frankfurt am Main, Hesse, Germany
Evangelisches Krankenhaus Wesel
Wesel, North Rhine-Westphalia, Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany