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Clinical trialNCT06153836RecruitingPhase 2Interventional

Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

SponsorMayo ClinicEnrollment45Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Mayo Clinic in Florida

    Jacksonville, Florida, United States

    James W. Jakub, M.D.Olivia S. Ho, M.D., M.S.
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
5 Dec 2023
Primary completion
10 Nov 2026
Completion
10 Nov 2026
Last update posted
19 Aug 2026
Registered enrollment
45
Registry id
NCT06153836
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.