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Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction

NCT06299332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-07

No results posted yet for this study

Summary

The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED).

Conditions

Interventions

DEVICE

Device treatment

20 heterosexual males clinically diagnosed with Erectile Dysfunction will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit

Sponsors & Collaborators

  • InMode MD Ltd.

    lead INDUSTRY

Principal Investigators

  • Robert Valenzuela, MD

  • Lanna Cheuck, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2024-05-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299332 on ClinicalTrials.gov