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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07480161
Eligibility Criteria:
Inclusion Criteria:
* Male patients aged 25 to 75 years
* Diagnosis of erectile dysfunction for at least 6 months
* Type 1 or Type 2 diabetes mellitus for at least 5 years
* Inadequate response to medical treatment, including phosphodiesterase type-5 (PDE-5) inhibitors and/or intracavernosal prostaglandin E1 therapy
* Candidates for penile prosthesis implantation due to treatment-resistant erectile dysfunction
* Ability and willingness to provide written informed consent
Exclusion Criteria:
* Penile anatomical deformities
* Active infection or skin lesion on the penis
* Bleeding disorders or coagulation abnormalities
* Previous penile prosthesis implantation, penile vascular surgery, or pelvic surgery
* Untreated hypogonadism
* Unstable cardiovascular disease
* History of malignancy
* Autoimmune disease
* Use of immunosuppressive therapy
* Presence of systemic or local infection
* Uncontrolled diabetes mellitus
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT07480161
Study Brief:
Protocol Section:
NCT07480161