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Clinical Trials in Germany / NCT06511167
Recruiting Observational

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

NCT06511167 · tracked via the Priya Life Science Germany tracker
Sponsor
AWOgyn
Phase
Observational
Started
2024-11-08
Last updated
2026-05-11

Condition(s) studied

Implant Based Breast Reconstruction

Investigational drug(s) / intervention(s)

TIGR® Matrix

TIGR® Matrix: bioresorbable, synthetic, surgical mesh

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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 100.000/µl * Lack or withdrawn of written patients informed consent * Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
GRN-Klinik Weinheim Weinheim Baden-Wurttemberg Active Not Recruiting
Klinik und Poliklinik für Frauenheilkunde Technische Universität München München Bavaria Recruiting
Agaplesion Markus Krankenhaus Frankfurt Frankfurt am Main Hesse Recruiting
Evangelisches Krankenhaus Wesel Wesel North Rhine-Westphalia Recruiting
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH Halle Germany Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06511167 on ClinicalTrials.gov ↗ ← All trials in Germany