<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484090</url>
  </required_header>
  <id_info>
    <org_study_id>OHH-FE-0.1</org_study_id>
    <nct_id>NCT04484090</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study</brief_title>
  <official_title>Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHH-MED Medical Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OHH-MED Medical Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient&#xD;
      for satisfactory sexual performance, is estimated to affect up to 30 million men in the&#xD;
      United States. The disorder is age-associated. The available treatments include oral therapy,&#xD;
      vacuum-constriction devices; shockwave therapy, intracavernosal injections of vasoactive&#xD;
      agents, including alprostadil (prostaglandin E1, transurethral delivery of alprostadil,&#xD;
      Implantation of penile prostheses.&#xD;
&#xD;
      The OhhMed Company has developed the Vertica device that provides treatments for improvement&#xD;
      of erectile function in patients with erectile dysfunction. This study assess the safety,&#xD;
      efficacy, ease of use, and satisfaction of the Vertica device by men with mild to moderate&#xD;
      erectile dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in erectile function (EF)</measure>
    <time_frame>Baseline to 1 month post intervention</time_frame>
    <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</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Vertica</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vertica RF device</intervention_name>
    <description>The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction</description>
    <arm_group_label>Vertica</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IIEF-EF score of 11-24 with or without the use of medication (PDE5 inhibitors).&#xD;
&#xD;
          -  Erectile dysfunction for at least 3- months&#xD;
&#xD;
          -  Steady relationship for at least 3-months.&#xD;
&#xD;
          -  patient without sensory disorders&#xD;
&#xD;
          -  patient with established organic of erectile dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  investigator's impression of expected poor patient compliance or anatomic inadequacy&#xD;
             (penile size/girth)&#xD;
&#xD;
          -  Premature ejaculation&#xD;
&#xD;
          -  Any psychiatric disorder&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Peyronie 's disease/ penile curvature&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Any tumor in the pelvic or penile region within the last 3 years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The OhhMed device provide treatments for improvement of erectile dysfunction</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilan Gruenwald, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Medical Center, Haifa Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Medical center</name>
      <address>
        <city>Haifa</city>
        <zip>3525408</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>January 29, 2023</last_update_submitted>
  <last_update_submitted_qc>January 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Erectile dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484090
org study id: OHH-FE-0.1
nct id: NCT04484090
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in erectile function (EF)
time frame: Baseline to 1 month post intervention
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
arm group label: Vertica
arm group type: Experimental
description: Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction
intervention type: Device
intervention name: Vertica RF device
description: The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction
arm group label: Vertica
criteria: 
gender: Male
gender based: Yes
gender description: The OhhMed device provide treatments for improvement of erectile dysfunction
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ilan Gruenwald, Prof.
role: Principal Investigator
affiliation: Rambam Medical Center, Haifa Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Erectile Dysfunction
sharing ipd: No