Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts (NCT06781606) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts
France3 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient ≥ 18 years and ≤ 60 years
* Patient with traumatic penile severe defects (amputation), or congenital penile defects (micropenis)
* ASA ≤ 2
* NYHA ≤ 1
* Creatinine clearance \> 60 mL/min (CKD-EPI)
* Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
* Informed consent signed to participate to the study
Exclusion Criteria:
* Gender incongruence
* Congenital penile defects resulting from exstrophy/epispadias
* Penile malformation due to selh-half/self-amputation
* Amputation for penile cancer
* Other types of malignancy in remission for less than 5 years
* Progressive malignant tumor
* Presenting hepatitis B, hepatitis C, or HIV infection not controlled by appropriate anti-viral therapy
* Uncontrolled arterial hypertension
* Moderate renal failure : glomerular filtration rate of less than 60 mL/min per 1.73 m2
* EBV sero-negative recipient with EBV sero-positive graft, due to the risk of lymphoma
* Non controlled chronic infection
* Malignancy, Connective tissue disease
* Amyloidosis
* Unbalanced diabetes
* Patient with a contraindication to performing an MRI examination
* Contra-indication of Thymoglobuline: Hypersensitivity to rabbit proteins or to any of the excipients of Thymoglobuline, acute or chronic infections that contraindicate any additional immunosuppression,
* Contra-inducation of tacrolimus: Hypersensitivity …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.