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:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT06094257
Eligibility Criteria:
Inclusion Criteria:
* Age over 18
* Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction
* Patient is capable and willing to provide informed consent
Exclusion Criteria:
* Patient has a nerve condition that does not allow for assessment of sensation
* Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
* Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
* Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06094257
Study Brief:
Protocol Section:
NCT06094257