Completed

Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study

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What is being tested

Vertica RF device

Device
Who is being recruted

Urogenital Diseases+5

+ Genital Diseases

+ Mental Disorders

From 40 to 85 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2019
See protocol details

Summary

Principal SponsorOHH-MED Medical Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 20, 2019

Actual date on which the first participant was enrolled.

Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is estimated to affect up to 30 million men in the United States. The disorder is age-associated. The available treatments include oral therapy, vacuum-constriction devices; shockwave therapy, intracavernosal injections of vasoactive agents, including alprostadil (prostaglandin E1, transurethral delivery of alprostadil, Implantation of penile prostheses. The OhhMed Company has developed the Vertica device that provides treatments for improvement of erectile function in patients with erectile dysfunction. This study assess the safety, efficacy, ease of use, and satisfaction of the Vertica device by men with mild to moderate erectile dysfunction.

Official TitleSafety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
NCT04484090
Principal SponsorOHH-MED Medical Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 40 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesMental DisordersGenital Diseases, MaleErectile DysfunctionSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
Erectile dysfunction for at least 3- months
IIEF-EF score of 11-24 with or without the use of medication (PDE5 inhibitors).
Steady relationship for at least 3-months.
patient without sensory disorders
Show More Criteria
7 exclusion criteria prevent from participating
investigator's impression of expected poor patient compliance or anatomic inadequacy (penile size/girth)
Premature ejaculation
Any psychiatric disorder
Epilepsy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Rambam Medical center

Haifa, IsraelOpen Rambam Medical center in Google Maps
CompletedOne Study Center