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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT07062458
Eligibility Criteria:
Inclusion Criteria:
* Female patients aged ≥18 years.
* Diagnosed with early-stage breast cancer or deemed at high risk for breast cancer (eg. BRCA1-2 mutations).
* Candidates for Nipple-Sparing Mastectomy (NSM).
* Able to provide informed consent.
* No contraindications for surgery based on physical examination and preoperative assessment.
* Signed the consent forms and willing to participate in all scheduled follow-up assessments.
Exclusion Criteria:
* Previous breast surgery.
* History of radiation therapy to the chest/breast area.
* Active or non-controlled diabetes mellitus.
* Neuropathies causing potentially altered skin sensation.
* Nipple involvement by cancer, clinical or reported intra-operatively via frozen section analysis (the procedure will be converted to SSM).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07062458
Study Brief:
Protocol Section:
NCT07062458