Evaluating the quality of life and safety of TIGR® Matrix after breast reconstruction
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
This study is testing how the TIGR® Matrix affects the quality of life and safety for women after they have breast reconstruction surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AWOgyn Academic / other |
| Locations | 5 sites (Weinheim, Baden-Wurttemberg and 4 other locations) |
| Trial ID | NCT06511167 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life of women who have undergone implant-based breast reconstruction using the TIGR® Matrix. Participants will complete the BREAST-Q questionnaire to evaluate their experiences post-surgery. The study will also monitor the safety and effectiveness of the resorbable surgical mesh, collecting data on any complications associated with its use. This multicenter investigation will provide valuable insights into the outcomes of this surgical approach.
Who should consider this trial
Good fit: Ideal candidates include women with confirmed breast cancer or high genetic risk for breast cancer who are undergoing skin-sparing or nipple-sparing mastectomy.
Not a fit: Patients who are pregnant, breastfeeding, or have metastatic breast cancer with a life expectancy of less than five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of patient quality of life and safety associated with the TIGR® Matrix in breast reconstruction.
How similar studies have performed: Other studies have shown promising results with similar approaches in evaluating quality of life and safety in breast reconstruction, suggesting a potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Weinheim, Baden-Wurttemberg and 4 other locations
- GRN-Klinik Weinheim — Weinheim, Baden-Wurttemberg, Germany (Active_not_recruiting)
- Klinik und Poliklinik für Frauenheilkunde Technische Universität München — München, Bavaria, Germany (Recruiting)
- Agaplesion Markus Krankenhaus Frankfurt — Frankfurt am Main, Hesse, Germany (Recruiting)
- Evangelisches Krankenhaus Wesel — Wesel, North Rhine-Westphalia, Germany (Recruiting)
- Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH — Halle, Germany (Recruiting)
Study contacts
- Study coordinator: Marc Thill, Prof.
- Email: Marc.Thill@agaplesion.de
- Phone: +49 69 95 33 22 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.