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NOT YET RECRUITING
NCT06781606
NA

Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2025-06-01

Completion Date

2031-06-01

Last Updated

2025-01-17

Healthy Volunteers

No

Interventions

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.

Locations (9)

Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Tripode CHU Bordeaux

Bordeaux, France

Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille

Lille, France

Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civils de Lyon

Lyon, France

Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception

Marseille, France

Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Saint Roch

Montpellier, France

Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier

Montpellier, France

Service d'urologie Hôpital Lyon Sud

Pierre-Bénite, France

Service d'urologie Hôpital Foch

Suresnes, France

Département d'urologie, andrologie et transplantation rénale Hôpital Rangueil CHU de Toulouse

Toulouse, France