NCT06511167 Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
| NCT ID | NCT06511167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AWOgyn |
| Condition | Implant Based Breast Reconstruction |
| Study Type | OBSERVATIONAL |
| Enrollment | 135 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 135 participants in total. It began in 2024-11-08 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 100.000/µl * Lack or withdrawn of written patients informed consent * Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol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.
Contact & Investigator
Marc Thill, Prof.
STUDY CHAIR
AWOgyn
Frequently Asked Questions
Who can join the NCT06511167 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Implant Based Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511167 currently recruiting?
Yes, NCT06511167 is actively recruiting participants. Contact the research team at Marc.Thill@agaplesion.de for enrollment information.
Where is the NCT06511167 trial being conducted?
This trial is being conducted at Weinheim, Germany, München, Germany, Frankfurt am Main, Germany, Wesel, Germany and 1 additional location.
Who is sponsoring the NCT06511167 clinical trial?
NCT06511167 is sponsored by AWOgyn. The principal investigator is Marc Thill, Prof. at AWOgyn. The trial plans to enroll 135 participants.