Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
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* Lack or withdrawn of written patients informed consent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)
Quality of Life 12 months after surgery (BREAST-Q) — 12 months after surgery Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
Trial sites (5)
Facility
City
Region
Status
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.
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