- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04484090
Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hanna Levy, PhD
- Phone Number: 9725228249
- Email: hanna@qsitemed.com
Study Locations
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Haifa, Israel, 3525408
- Recruiting
- Rambam Medical Center
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Contact:
- Hanna Levy, PhD
- Phone Number: 9725228249
- Email: hanna@qsitemed.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vertica
Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction
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The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in erectile function (EF)
Time Frame: Baseline to 1 month post intervention
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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
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Baseline to 1 month post intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ilan Gruenwald, Prof., Rambam Medical Center, Haifa Israel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHH-FE-0.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
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Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
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University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
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