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New treatment option for Erectile Dysfunction
Official title A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction
ClinicalTrials.gov ID: NCT07592533
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patient is over the age of 18
- Patient has a natal penis (not a neophallus)
- Patient has ED (defined as IIEF-EF of 25 or less) and EHS \< 2 on at least 50% of sexual encounters
- Patient understands and is able to articulate necessary study procedures and tests
- Patient has the mental capacity to provide written and verbal informed consent
You likely can't join if
- Placement of a penile prosthesis (malleable or inflatable type)
- Have a serious medical condition/illness that makes safety or compliance with study procedures and/or engagement in sexual activity inadvisable in...
- Untreated severe psychological disease (e.g., psychosis, bipolar disorder)
See the full eligibility criteria
- Patient is over the age of 18
- Patient has a natal penis (not a neophallus)
- Patient has ED (defined as IIEF-EF of 25 or less) and EHS \< 2 on at least 50% of sexual encounters
- Patient understands and is able to articulate necessary study procedures and tests
- Patient has the mental capacity to provide written and verbal informed consent
- Patient endorses the ability to comply with study procedures throughout the duration of the study
- Placement of a penile prosthesis (malleable or inflatable type)
- 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
- Untreated severe psychological disease (e.g., psychosis, bipolar disorder)
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.