RecruitingNCT06511167

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

Sponsor

AWOgyn

Enrollment

135 participants

Start Date

Nov 8, 2024

Study Type

OBSERVATIONAL

Conditions

Implant Based Breast Reconstruction

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: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria9

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Lack or withdrawn of written patients informed consent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.

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