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

AWOgyn

Status: Enrolling

Conditions: Implant Based Breast Reconstruction

Treatments: Device: TIGR® Matrix

Study type: Observational

Funder types: Other

Identifiers

NCT06511167

AWO-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Lack or withdrawn of written patients informed consent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.