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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Nov 10, 2026 → Jul 19, 2028
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Nov 10, 2026 to Jul 19, 2028
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: details revised at 8 of 8 entries
  2. Enrollment increased: 20 → 45 participantsv10
  3. Enrollment target: 14 to 20v9
  4. Primary and study completion dates: Nov 10, 2025 to Nov 10, 2026v8
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Secondary endpoints: details revised at 6 of 8 entries
    • Eligibility criteria expanded, about 1 word
    v6
  2. Eligibility criteria shortened, about 16 wordsv5
  3. Eligibility criteria expanded, about 1 wordv4
  4. Site contact updated
    • Eligibility criteria shortened, about 1 word
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2024 to Dec 5, 2023
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
1,024 trials monitored
See 128 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
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.
Trial Details
NCT Number NCT06153836
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
Related terms Breast Carcinoma In Situ
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov