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Procedure

Active for Erectile Dysfunction

N/A
Recruiting
Research Sponsored by OHH-MED Medical Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Adult, heterosexual, males between 22 and 85 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will study mild-moderate ED patients to see if a device can help them have successful sexual activity. Home use of the device for 6 months, with monthly follow-ups, will be part of the study.

Who is the study for?
This trial is for heterosexual male adults aged 22-85 with mild to moderate erectile dysfunction (ED) for at least 3 months. Participants must have a steady relationship, be sexually active, and own a smartphone. They can't join if they've had certain pelvic treatments or conditions, take specific medications, have major neurological issues, psychiatric disorders including premature ejaculation and substance abuse problems, or if their partner is pregnant.Check my eligibility
What is being tested?
The VERTICA® RF Device's safety and effectiveness in treating ED are being tested. Men will randomly receive either the real device or a sham (fake) version to use at home for six months. They'll try sexual activity regularly and log each event while attending monthly check-ups where safety checks and more efficacy tests happen.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from using the device or skin irritation at the site of application based on similar devices' profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with erectile dysfunction for at least 3 months.
Select...
I am a heterosexual male aged between 22 and 85.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A significant change from baseline in the mean International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, within the VERTICA Active treatment group.
A significant difference in the mean change from baseline in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, between the treatment groups.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

OHH-MED Medical LtdLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
28 Patients Enrolled for Erectile Dysfunction

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to participate in this research project?

"The requirements to join this trial are having erectile dysfunction and being between 22-85 years old. Approximately 98 individuals will be accepted into the study."

Answered by AI

How many participants are being enrolled in this medical research project?

"Affirmative. According to clinicaltrials.gov, this medical trial has been recruiting since November 29th 2023 and is still actively doing so as of December 4th 2023. The research aims to include 98 participants from one site in the study."

Answered by AI

Is recruitment still available for this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this research project is currently recruiting participants, with the first post being published on November 29th 2023 and edited most recently on December 4th 2023. Ninety-eight individuals are sought for a single site trial."

Answered by AI

Is eligibility restricted to those over 50 years old for this research endeavor?

"This trial is recruiting patients between the ages of 22 to 85, with separate studies being conducted for those under 18 and over 65. Specifically, 3 trials are available for younger individuals and 59 have been set up for seniors."

Answered by AI

Who else is applying?

What site did they apply to?
University of California, Irvine Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I have tried one other drug and it didn’t work at all .
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
2023. "Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06167733.
All > Erectile Dysfunction
~53 spots leftby Oct 2024
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