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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT06600893
Eligibility Criteria:
Inclusion Criteria:
1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
2. Subject is male;
3. Subject is aged 21-80 years;
4. Subject is in a relationship with a female partner for at least 3 months;
5. Subject has a body mass index (BMI) \< 37 kg/m2;
6. Subject has erectile dysfunction;
7. Subject has testosterone ≥ 300;
8. Subject has a prostate specific antigen (PSA) \< 4.0;
9. Subject is willing to attempt sexual activity at least 4 times during the screening period and 4 weeks before each follow-up visit;
10. Subject is willing to stop all erectile function aids (e.g. prescription and non-prescription medications, injections, vacuum erection devices, constriction ring) during the screening period and 4 weeks before each follow-up visit;
11. Subject agrees to comply with the study procedures and visits.
Exclusion Criteria:
1. Subject has been treated with acoustic wave previously;
2. Subject has a pacemaker or implanted defibrillator;
3. Subject has clinically significant findings on physical examination;
4. Subject has sciatica or severe back pain;
5. Subject has uncontrolled hypertension;
6. Subject has uncontrolled hypogonadism;
7. Subject is unwilling to maintain testosterone replacement therapy if currently using testosterone to treat hypogonadism;
8. Subject scores ≥ 26 on the IIEF;
9. Subject has homogenous corpora cavernosa on grey scale ultrasound;
10. Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes him ineligible for the study;
11. Subject has lesions or active infections on the penis or perineum;
12. Subject is unwilling to remove piercings from the genital region;
13. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
14. Subject has received an investigational drug within 30 days prior to signing consent;
15. Subject has received platelet rich plasma (PRP) within 3 months of signing consent;
16. Subject has received stem cell within 6 months of signing consent;
17. Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT06600893
Study Brief:
Protocol Section:
NCT06600893