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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT03039218
Eligibility Criteria:
Inclusion Criteria:
1. Consent to participate.
2. Age 22-70 years.
3. Presence of Vasculogenic Erectile Dysfunction for at least 6 months.
4. Having some response to a PDE5i. Last PDE5i use must be within 30 days of Screening Visit.
5. IIEF-EF score ≥17 up to ≤30 while taking PDE5i.
6. IIEF-EF score ≥17 up to ≤25 after wash out of PDE5i.
7. In a stable heterosexual relationship of more than three months duration.
8. Sexually active and agree to suspend all ED therapy for duration of study.
9. Agree to maintain their normal sexual habits.
Exclusion Criteria:
1. Radical prostatectomy.
2. Previous radiation therapy to pelvis.
3. Previous stem cell or platelet rich plasma therapy.
4. Previous pelvic surgeries that in the judgment of the investigator could impact on erectile function such as radical prostatectomy, radical cystectomy, Peyronie's disease surgery, penile lengthening or penile cancer surgery.
5. Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
6. Hormone usage, other than testosterone, clomiphene or thyroid medication.
7. Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine as demonstrated in the drug screen.
8. Psychogenic ED.
9. Peyronie's Disease or penile curvature that negatively influences sexual activity.
10. Current anticoagulation therapy or significant hematological conditions as demonstrated in abnormal values in the complete blood count.
11. Liver disease as demonstrated by abnormal chemistry panel or coagulation values in the prothrombin time (PT) along with its derived measures of prothrombin ratio (PR) blood tests.
12. Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater than 1197 ng/dL.
13. Patients with cardiac or non-cardiac electrical devices implanted.
14. Anatomical or neurological abnormalities in the treatment area.
15. Diabetes Mellitus with severe polyneuropathy.
16. Patients with generalized polyneuropathy irrespective of cause.
17. Refusal to suspend ED therapy for duration of study.
18. Men deemed not healthy enough to participate in sexual activity.
19. IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period.
20. Average EHS ≤ 2 at baseline assessment following "washout".
21. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
22. Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
23. Known allergy to ultrasound gel.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
22 Years
Maximum Age:
70 Years
Study:
NCT03039218
Study Brief:
Protocol Section:
NCT03039218