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:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT05756803
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Men aged 18-64
4. Sexually active men and evidence of increased firmness on elastography during their standard evaluation for erectile dysfunction.
Exclusion Criteria:
1. Within two weeks of Visit 1 using erectogenic medications including PDE5 inhibitors and/or penile injection therapy
2. Presence of a penile implant.
3. Presence of cardiac pacemaker or defibrillator
4. Patients who are using devices which are sensitive to electromagnetic radiation.
5. Screening ultrasound positive for testicular cancer
6. Presence of untreated prostate cancer
7. Patients with severe coagulation disorders
8. Patient that in the opinion of the Principal Investigator would be non-compliant with the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05756803
Study Brief:
Protocol Section:
NCT05756803