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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 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.

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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.

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

FieldValue
Enrollment Target 98 participants
Start Date 2023-11-29
Est. Completion 2026-10-01
Phase NA

Sponsor

OHH-MED Medical

1 total trials

What the Registry Record Tells You About NCT06167733

The ClinicalTrials.gov registry entry for NCT06167733 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 229-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (57% lower). The listed sponsor is OHH-MED Medical, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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