Back to resultsSafety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vertica RF device
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction
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
Sites / Locations
- Rambam Medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vertica
Arm Description
Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction
Outcomes
Primary Outcome Measures
Change in erectile function (EF)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04484090
Brief Title
Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
Official Title
Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHH-MED Medical Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vertica
Arm Type
Experimental
Arm Description
Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction
Intervention Type
Device
Intervention Name(s)
Vertica RF device
Intervention Description
The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction
Primary Outcome Measure Information:
Title
Change in erectile function (EF)
Description
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
Time Frame
Baseline to 1 month post intervention
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
The OhhMed device provide treatments for improvement of erectile dysfunction
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, Prof.
Organizational Affiliation
Rambam Medical Center, Haifa Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical center
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
We'll reach out to this number within 24 hrs