NCT06511167

Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 135 (estimated)
• Sponsor: AWOgyn · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.

Conditions

• Implant Based Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	TIGR® Matrix	bioresorbable, synthetic, surgical mesh

Timeline

• Start date: 2024-11-08
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-07-19
• Last updated: 2025-04-15

Locations

5 sites across 1 country: Germany