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Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED
NCT06167733 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06167733
The ClinicalTrials.gov registry entry for NCT06167733 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OHH-MED Medical, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06167733 reports 7 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06167733?
The interventions under investigation include: VERTICA Active device (DEVICE), VERTICA Sham device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06167733?
This trial is sponsored by OHH-MED Medical, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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