Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
Recruiting
N/A
Interventional Study
Erectile Dysfunction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 22 – 85
- Sex
- Male
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 98 (estimated)
- Sponsor
- OHH-MED Medical Ltd · Industry
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About This Trial
Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment sessi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult, heterosexual, males between 22 and 85 years of age
* Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).
* Subjects with an IIEF-EF sco…
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