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Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

NCT06781606 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-01-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • French Association of Urology

    collaborator UNKNOWN

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Paul Neuville, Doctor · Service d'urologie Hôpital Lyon Sud

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2030-06-01
Completion
2031-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06781606 on ClinicalTrials.gov