NCT07592533 A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction
| NCT ID | NCT07592533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Erectile Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 157 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 157 participants in total. It began in 2024-09-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a device study (while the device has been patented and cleared by the FDA, the indication of the use for Erectile Dysfunction has been yet approve). EXSTACY is a study to collect information on which patients who have trouble getting or keeping an erection rigid enough for sex (sometimes known as Erectile Dysfunction or ED) benefit from light intensity shockwave therapy (LI-SWT). LI-SWT is a form of energy transfer to the penis that has been shown to help some men with ED in studies over the past decade. This study will collect information about patients prior to treatment to determine what predicts a good outcome. The investigators hope that this information will help decide which patients are likely to benefit from LI-SWT and which patients should consider other treatments for ED.
Eligibility Criteria
Inclusion Criteria: 1. Patient is over the age of 18 2. Patient has a natal penis (not a neophallus) 3. Patient has ED (defined as IIEF-EF of 25 or less) and EHS \< 2 on at least 50% of sexual encounters 4. Patient understands and is able to articulate necessary study procedures and tests 5. Patient has the mental capacity to provide written and verbal informed consent 6. Patient endorses the ability to comply with study procedures throughout the duration of the study Exclusion Criteria: 1. Placement of a penile prosthesis (malleable or inflatable type) 2. Have a serious medical condition/illness that makes safety or compliance with study procedures and/or engagement in sexual activity inadvisable in the opinion of the PI 3. Untreated severe psychological disease (e.g., psychosis, bipolar disorder)
Contact & Investigator
Alan W. Shindel, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07592533 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07592533 currently recruiting?
Yes, NCT07592533 is actively recruiting participants. Contact the research team at Karina.Acevedo@ucsf.edu for enrollment information.
Where is the NCT07592533 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07592533 clinical trial?
NCT07592533 is sponsored by University of California, San Francisco. The principal investigator is Alan W. Shindel, MD, MAS at University of California, San Francisco. The trial plans to enroll 157 participants.