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

NCT06511167 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Implant Based Breast Reconstruction

Interventions

DEVICE

TIGR® Matrix

bioresorbable, synthetic, surgical mesh

Sponsors & Collaborators

  • Esculape GmbH

    collaborator UNKNOWN

  • AWOgyn

    lead OTHER

Principal Investigators

  • Marc Thill, Prof. · AWOgyn

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06511167 on ClinicalTrials.gov