Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT06781606
Eligibility Criteria:
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 to tacrolimus or others macrolides, or any of the excipients of PROGRAF,
* Contra-indication of Mycophenolate mofetil: in patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients, Hypersensitivity reactions to mycophenolate mofetil;
* History of major psychiatric disorders \< 3 years (psychotic disorders, severe substance abuse, severe personality disorders) or persons under psychiatric care ;
* Person deprived of their liberty by a judicial or administrative decision ;
* Person admitted to a health or social institution for purposes other than research
* Adult subjects to a legal protection measure (guardianship, curatorship)
* Person not affiliated to a social security scheme of beneficiaries of a similar scheme
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06781606
Study Brief:
Protocol Section:
NCT06781606