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Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

StatusEnrolling by Invitation
PhasePhase 2/3
Started2023-08-01
View on ClinicalTrials.gov ↗

Amendment history

2025-10-16
Study Status, Oversight v3
Primary completion date2026-06-01→2028-12-30
Completion date2026-12-01→2029-12-01
2024-09-30
Study Status v2
Start date2021-08-01→2023-08-01
2023-09-07
Recruiting→Enrolling by Invitation Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusRecruiting→Enrolling by Invitation
Primary completion date2025-06-01→2026-06-01
Completion date2025-07-01→2026-12-01
Start dateestimated 2023-06-03→confirmed 2021-08-01
Eligibility criteria-191 characters
Inclusion Criteria: We will consider subjects over the age of 18 with a preoperative diagnosis of gender dysphoria and present for planned radial forearm free flap phalloplasty. Participants must be willing to comply with all aspects of treatment (post-operative visits) as well as the study evaluation schedule (follow-up visits up to 15 months postoperatively). Exclusion Criteria: Patients will be excluded from enrollment if they have a known allergy to the study drug, a hematocrit of 54% or higher, or a history of venous thromboembolism (VTE), peripheral phleb [...]
Secondary endpointsdetails revised at 1 of 2 entries
Study description+84 characters
With more than 1.6 million transgender and nonbinary (TGNB) individuals in the United States, wethe investigators have witnessed an exponential increase in the number of gen [...] ive effects of axonal degeneration that occurs post-injury. WeThe investigators advocate for using polyethylene glycol as a "fusogen" to ac [...] ility to conduct electrical signals across the repair site. OurThe groupinvestigators hashave conducted extensive mammalian and preliminary human studies [...] PEG fusion of injured digital nerves performed by our team, wethe investigators saw rapid nerve recovery and early functional outcomes [...] [...]
Study sitesdetails revised at 1 of 1 site
2023-06-01
Original filing
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.
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