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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Implant Based Breast Reconstruction
• Intervention / Treatment: Device: TIGR® Matrix

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 Type: Observational
• Enrollment (Estimated): 135

Contacts and Locations

• Study Contact: Name: Marc Thill, Prof.; Phone Number: +49 69 95 33 22 28; Email: Marc.Thill@agaplesion.de

Study Locations

• Germany
  • Halle, Germany, 06110
    • Recruiting
    • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
    • Contact: Tilmann Lantzsch, Dr. med.; Phone Number: +49 345 213 4341; Email: t.lantzsch@krankenhaus-halle-saale.de
    • Principal Investigator: Tilmann Lantzsch, Dr. med.
  • Baden-Wurttemberg
    • Weinheim, Baden-Wurttemberg, Germany, 69469
      • Active, not recruiting
      • GRN-Klinik Weinheim
  • Bavaria
    • München, Bavaria, Germany, 80337
      • Recruiting
      • Klinik und Poliklinik für Frauenheilkunde Technische Universität München
      • Contact: Evelyn Klein, Dr. med.; Phone Number: +49 89 41402433; Email: evelyn.klein@tum.de
      • Principal Investigator: Evelyn Klein, Dr. med.
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60431
      • Recruiting
      • Agaplesion Markus Krankenhaus Frankfurt
      • Contact: Katharina Kelling, Dr. med.; Phone Number: +49 69 95 33 66 754; Email: katharina.kelling@agaplesion.de
      • Principal Investigator: Katharina Kelling, Dr. med.
  • North Rhine-Westphalia
    • Wesel, North Rhine-Westphalia, Germany, 46485
      • Recruiting
      • Evangelisches Krankenhaus Wesel
      • Contact: Daniela Rezek, Dr. med.; Phone Number: +49 281 106 2324; Email: daniela.rezek@evkwesel.de
      • Principal Investigator: Daniela Rezek, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women who will undergo breast prepectoral implant-based breast reconstructive surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life 12 months after surgery (BREAST-Q)	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	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life 6, 24, 36 months after surgery (BREAST-Q)	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	6, 24, 36 months after surgery
Complication rate of specific complications	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)	minimum of 3 years and a maximum of 5 years after surgery
Days with drain(s)	The number of days between placement of drain system and removal of the drain	during hospital stay after surgery
Days of hospital stay	The number of days the participant spend in hospital after surgery	surgery to discharge from hospital
Cosmetic outcome	Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician	6, 12, 24 ,36 month after surgery
Rate of unplanned conversion operations	Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction)	minimum of 3 years and a maximum of 5 years after surgery
Complication rate	The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs)	minimum of 3 years and a maximum of 5 years after surgery

Collaborators and Investigators

• Sponsor: AWOgyn
• Collaborators: Esculape GmbH
• Investigators: Study Chair: Marc Thill, Prof., AWOgyn

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; TIGR® Matrix
• Other Study ID Numbers: AWO-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No