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

NCT ID: NCT04484090

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2021-09-20

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vertica

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

Group Type: EXPERIMENTAL

Vertica RF device

Intervention Type: DEVICE

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

Interventions

Vertica RF device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

OHH-MED Medical Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilan Gruenwald, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rambam Medical Center, Haifa Israel

Locations

Rambam Medical center

Haifa, , Israel

Countries

Israel

Other Identifiers

OHH-FE-0.1

Identifier Type: -

Identifier Source: org_study_id