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

NCT04484090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-01-31

No results posted yet for this study

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

Interventions

DEVICE

Vertica RF device

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

Sponsors & Collaborators

  • OHH-MED Medical Ltd

    lead INDUSTRY

Principal Investigators

  • Ilan Gruenwald, Prof. · Rambam Medical Center, Haifa Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-20
Primary Completion
2021-09-20
Completion
2021-09-20

Countries

  • Israel

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 NCT04484090 on ClinicalTrials.gov