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

Recruiting

• Conditions: Implant Based Breast Reconstruction

• Registration Number: NCT06511167
• Lead Sponsor: AWOgyn

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-19
• Study Start: 2024-11-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 135

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• Lack or withdrawn of written patients informed consent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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Quality of Life 6, 24, 36 months after surgery (BREAST-Q)	6, 24, 36 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
Complication rate	minimum of 3 years and a maximum of 5 years after surgery	The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs)
Complication rate of specific complications	minimum of 3 years and a maximum of 5 years after surgery	Complication rate of: * Seroma-Volume (Sum of fluid-volume during the drainage-time); * Need for aspiration in symptomatic patients, number of aspirations in postoperative follow up; * Reconstructive failure (defined as unplanned implant loss)
Days with drain(s)	during hospital stay after surgery	The number of days between placement of drain system and removal of the drain
Days of hospital stay	surgery to discharge from hospital	The number of days the participant spend in hospital after surgery
Cosmetic outcome	6, 12, 24 ,36 month after surgery	Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician
Rate of unplanned conversion operations	minimum of 3 years and a maximum of 5 years after surgery	Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction)

Trial Locations

Locations (5)

GRN-Klinik Weinheim; 🇩🇪 Weinheim, Baden-Württemberg, Germany

Klinik und Poliklinik für Frauenheilkunde Technische Universität München; 🇩🇪 München, Bayern, Germany

Agaplesion Markus Krankenhaus Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany

Evangelisches Krankenhaus Wesel; 🇩🇪 Wesel, Nordrhein-Westfalen, Germany

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH; 🇩🇪 Halle (Saale), Germany