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:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07177833
Eligibility Criteria:
Inclusion Criteria:
1. Men 18 or older. For heterosexual men it is required they be in a stable relationship with a female spouse/partner for at least 3 months and willing to have vaginal intercourse for purposes of properly filling out the validated PD Questionnaire.
2. Diagnosis of PD for at least 12 months with evidence of stable disease as determined by the investigator (i.e. no change in penile curve for at least 6 months and absence of pain).
3. Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane (must be possible to delineate the single plane of maximal curvature for evaluation)
4. Signed informed REB-approved consent agreement; signed authorization form to allow disclosure of protected information.
5. Ability to read, complete, and understand the various rating instruments in English.
Exclusion Criteria:
1. Penile curvature of \<30º or \>90º
2. Any conditions affecting the penis such as a chordee in the presence or absence of hypospadias; thrombosis of the dorsal penile artery; infiltration by a benign or malignant mass or an infectious agent; ventral curvature from any cause; presence of an active sexually transmitted disease.
3. Failure to achieve a sufficient 8/10 erection (after prostaglandin E or Trimix administration), in the opinion of the investigator, to accurately measure the penile deformity.
4. Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with Fractional CO2 Laser
5. Isolated hourglass deformity of the penis without curvature
6. Treatment or plans to undergo treatment for PD, including but not limited to any previous surgery, oral/topical agents within 3 months, intralesional medical therapies within 3 months, extracorporeal shock wave therapy within 6 months, or use of mechanical devices within 2 weeks before the start of the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07177833
Study Brief:
Protocol Section:
NCT07177833