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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04484090

Enrollment

Registered

2020-07-23

Start date

2019-01-20

Completion date

2021-09-20

Last updated

2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction

Brief summary

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.

Interventions

DEVICEVertica RF device

The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* IIEF-EF score of 11-24 with or without the use of medication (PDE5 inhibitors). * Erectile dysfunction for at least 3- months * Steady relationship for at least 3-months. * patient without sensory disorders * patient with established organic of erectile dysfunction

Exclusion criteria

* investigator's impression of expected poor patient compliance or anatomic inadequacy (penile size/girth) * Premature ejaculation * Any psychiatric disorder * Epilepsy * Peyronie 's disease/ penile curvature * Coagulopathy * Any tumor in the pelvic or penile region within the last 3 years

Design outcomes

Primary

Measure	Time frame	Description
Change in erectile function (EF)	Baseline to 1 month post intervention	The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026