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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05108558
Eligibility Criteria:
Inclusion Criteria:
* Men with Peyronie's Disease
* \>18 years old
* Curvature ≥30 degrees
* Previously completed 6-8 CCH injections
* Prior minimal (\<20% and/or \<10 degrees) responsiveness to CCH administration
* Prior CCH injections must have been performed without use of a Restorex traction device and used the IMPRESS protocol
* Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
* The patient exhibits a palpable plaque consistent with Peyronie's Disease
Exclusion Criteria:
* Prior surgical treatment on the penis (other than circumcision)
* Any contraindications to CCH - as determined by the PI
* Inability to complete 8 additional CCH injections
* Severe plaque calcification (i.e. \>1 cm shadowing)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05108558
Study Brief:
Protocol Section:
NCT05108558