NCT06781606

Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Penile transplantation (PT) has recently emerged as an option for penile reconstruction and has shown encouraging outcomes at the international level with two ongoing PT program (US, South Africa). Emergence of such option has been possible thanks to the development of vascularized composite allotransplantation and because of the important limitations of autologous reconstruction (phalloplasty). Feasibility has already been proven, but the surgical management remains in its infancy and has never been tested at a European level. Furthermore, the balance between functional improvement and immunosuppressive risk still needs to be enlightened.

Conditions

• Adults with Traumatic Penile Severe Defects
• Congenital Penile Defects
• Micropenis

Interventions

Type	Name	Description
PROCEDURE	Penile transplantation	The penile transplantation will take place at the Edouard Herriot hospital, part of the Hospices Civils de Lyon. It will be carried out on the same day or the day after the harvesting depending on the timing of the harvesting.

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-06-01
• Completion: 2031-06-01
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

9 sites across 1 country: France