Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT06511167
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* Lack or withdrawn of written patients informed consent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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06511167
Study Brief:
Protocol Section:
NCT06511167