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A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction

NCT07592533 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Shockwave therapy

The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.

Sponsors & Collaborators

Principal Investigators

  • Alan W. Shindel, MD, MAS · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07592533 on ClinicalTrials.gov