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

Ohh-Med Medical

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Device: Vertica RF device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04484090

OHH-FE-0.1

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Vertica

Experimental group

Description:

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

Treatment:

Device: Vertica RF device