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RECRUITING
NCT06511167

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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