Evaluating the quality of life and safety of TIGR® Matrix after breast reconstruction
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
Run by AWOgyn · NCT06511167 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 135 (estimated) |
| Sponsor | AWOgyn Academic / other |
| Locations | 5 sites (Weinheim, Baden-Wurttemberg and 4 other locations) |
| Status | Recruiting |
| Started | November 8, 2024 |
| Main results expected | January 2029 |
| Study ends | January 2029 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT06511167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar approaches in evaluating quality of life and safety in breast reconstruction, suggesting a potential for success.
Who can join: the full rules
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 it's running
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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 -
GRN-Klinik Weinheim
Weinheim, Baden-Wurttemberg, Germany Active not recruiting
Study contacts
- Study coordinator: Marc Thill, Prof.
- Email: Marc.Thill@agaplesion.de
- Phone: +49 69 95 33 22 28
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Investigation of FlexHD® Pliable in Breast Reconstruction
This study is testing a new material called FlexHD® Pliable to see if it can improve the results of breast reconstruction surgery for women getting implants right after their mastectomy.
-
Blossom Smart Expander for two-stage implant breast reconstruction or augmentation
This study will test whether the Blossom Smart Expander, which slowly and continuously delivers small amounts of saline, can replace regular needle fills for women having two-stage implant-based breast reconstruction or augmentation.
-
Mastectomy Expander-Based Reconstruction: Comparing Expander Options and Outcomes
This study tests whether different prepectoral tissue expander approaches lead to better breast shape and fewer complications after mastectomy and reconstruction.
-
Hypofractionated vs. standard radiotherapy after mastectomy with implant reconstruction
This trial tests whether shorter, higher-dose radiotherapy schedules after implant-based mastectomy reconstruction work as well as the traditional longer schedules for preventing unplanned reoperations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.