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

NCT06511167 | Recruiting DMC

• 1 other identifier: AWO-001
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 5

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.

Conditions

Implant Based Breast Reconstruction

Keywords

TIGR® Matrix; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of Life 6, 24, 36 months after surgery (BREAST-Q)

  6, 24, 36 months after surgery

• Complication rate

  minimum of 3 years and a maximum of 5 years after surgery

• Complication rate of specific complications

  minimum of 3 years and a maximum of 5 years after surgery

• Days with drain(s)

  during hospital stay after surgery

• Days of hospital stay

  surgery to discharge from hospital

Interventions

TIGR® Matrix DEVICE

bioresorbable, synthetic, surgical mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AWOgyn: lead
• Esculape GmbH: collaborator

Study Sites (5)

GRN-Klinik Weinheim

Weinheim, Baden-Wurttemberg, 69469, Germany

ACTIVE NOT RECRUITING

Klinik und Poliklinik für Frauenheilkunde Technische Universität München

München, Bavaria, 80337, Germany

RECRUITING

Agaplesion Markus Krankenhaus Frankfurt

Frankfurt am Main, Hesse, 60431, Germany

RECRUITING

Evangelisches Krankenhaus Wesel

Wesel, North Rhine-Westphalia, 46485, Germany

RECRUITING

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

Halle, 06110, Germany

RECRUITING

Study Officials

• Marc Thill, Prof.

  AWOgyn

  STUDY CHAIR

Central Study Contacts

Marc Thill, Prof.

CONTACT

+49 69 95 33 22 28; Marc.Thill@agaplesion.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 19, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

DE (5)