Clinical Trial

Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

Enrolling by Invitation Phase 2/3
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Summary
Phalloplasty, a genitourinary surgery for transmasculine patients, reconstructs a neophallus using tissue transferred from other parts of the body to the groin. However, this technique fails to provide adequate sensation, causing regret and persistent dysphoria. Peripheral nerve regeneration is the greatest barrier to sensory recovery, given the slow rate of regrowth coupled with the negative effects of axonal degeneration. Topical application of polyethylene glycol (PEG) fuses severed axonal membranes, restoring the nerve's immediate ability to conduct electrical signals across the repair site. The investigators hypothesize that utilizing PEG in phalloplasties will significantly improve neophallus sensation and postoperative quality of life.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-06-01; most recent amendment 2025-10-16.
Status change: Recruiting → Enrolling by Invitation 2023-09-07
Trial Details
NCT Number NCT05897086
Lead Sponsor Vanderbilt University Medical Center
Conditions Gender Dysphoria
Enrollment 30 participants
Start Date 2023-08-01
Primary Completion 2028-12-30 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-20