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Recruiting NCT06511167

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

— Observational Implant Based Breast Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TIGR® Matrix.
Who it may be relevant to
Registry conditions: Implant Based Breast Reconstruction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device TIGR® Matrix
    bioresorbable, synthetic, surgical mesh

Primary outcome measures

  • Quality of Life 12 months after surgery (BREAST-Q) [Time frame: 12 months after surgery]
Secondary outcome measures (7)
  • Quality of Life 6, 24, 36 months after surgery (BREAST-Q) [Time frame: 6, 24, 36 months after surgery]
  • Complication rate [Time frame: minimum of 3 years and a maximum of 5 years after surgery]
  • Complication rate of specific complications [Time frame: minimum of 3 years and a maximum of 5 years after surgery]
  • Days with drain(s) [Time frame: during hospital stay after surgery]
  • Days of hospital stay [Time frame: surgery to discharge from hospital]
  • Cosmetic outcome [Time frame: 6, 12, 24 ,36 month after surgery]
  • Rate of unplanned conversion operations [Time frame: minimum of 3 years and a maximum of 5 years after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 5 centers
  • GRN-Klinik Weinheim — Weinheim
  • Klinik und Poliklinik für Frauenheilkunde Technische Universität München — München
  • Agaplesion Markus Krankenhaus Frankfurt — Frankfurt am Main
  • Evangelisches Krankenhaus Wesel — Wesel
  • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH — Halle

Identifiers

NCT: NCT06511167 · AWO-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗