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Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 1 entry
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with implant-based breast reconstruction. The main questions it aims to answer are: * Does nerve grafting improve objective breast sensation compared with reconstruction without nerve grafting? * Does nerve grafting improve patient-reported breast sensation? Researchers will compare the breast that receives the nerve graft with the breast that does not receive a nerve graft to determine whether nerve grafting improves sensory recovery. Participants will: * Undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction as planned standard care. * Receive an allogeneic nerve graft (Avance Nerve Scaffold) on one breast, with the side receiving the graft determined randomly. * Have breast sensation measured using a light-touch test before surgery and at approximately 6, 12, and 24 months after surgery. * Complete questionnaires about breast sensation at the same time points.
Trial Details
NCT Number NCT07819357
Lead Sponsor Endeavor Health
Conditions
(from sponsor)		 Breast Reconstruction Following Mastectomy
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov