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NCT06167733 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
A NA study of Erectile Dysfunction, sponsored by OHH-MED Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 98
- Enrollment target
- 7
- Study locations
NCT06167733: Recruiting NA study of Erectile Dysfunction, sponsored by OHH-MED Medical.
NCT06167733 is a NA study of Erectile Dysfunction that is actively recruiting participants, run by OHH-MED Medical. The registered enrollment target is 98 participants, below the 229-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (57% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06167733, a NA study of Erectile Dysfunction, is actively recruiting participants, sponsored by OHH-MED Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
- 7
- Study locations
Study Summary
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 session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.
Primary Outcome
The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.
Conditions Studied
Interventions
- DEVICE VERTICA Active device
- DEVICE VERTICA Sham device
Study Locations (7)
California
- University of California, Irvine Medical Center - Newport Beach
- San Diego Sexual Medicine - San Diego
Florida
- Optimal Health Miami - Aventura
Illinois
- The University of Chicago - Chicago
Maryland
- Rachel Rubin MD - Bethesda
Ohio
- Cleveland Clinic - Cleveland
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2026-10-01 |
| Phase | NA |
What NCT06167733 shows while recruiting
NCT06167733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 229-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Erectile Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which VERTICA Active device is the first listed.
NCT06167733 lists 7 locations in 6 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT06167733 about?
NCT06167733 is a clinical study titled "Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED". 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, medi...
What is the current status of trial NCT06167733?
This trial is currently recruiting. It is a NA study. The enrollment target is 98 participants. The study started on 2023-11-29. Estimated completion is 2026-10-01.
What conditions does trial NCT06167733 study?
This clinical trial studies the following conditions: Erectile Dysfunction.
What interventions are being tested in trial NCT06167733?
The interventions under investigation include: VERTICA Active device (DEVICE), VERTICA Sham device (DEVICE).
Who is sponsoring clinical trial NCT06167733?
This trial is sponsored by OHH-MED Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06167733 being conducted?
This trial has 7 study locations across California, Florida, Illinois, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06167733's enrollment target sits among peer trials
98 16th of 33 higher than 18 of 33 other Erectile Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Erectile Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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