<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/NCT03038659</url>
  </required_header>
  <id_info>
    <org_study_id>2018</org_study_id>
    <nct_id>NCT03038659</nct_id>
  </id_info>
  <brief_title>Role of Intima-media Thickness in Determining Arteriogenic Erectile Dysfunction</brief_title>
  <official_title>Predictive Value of Measuring Intima-media Thickness of Cavernosal Artery in Diagnosis of Arteriogenic Erectile Dysfunction by Penile Duplex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adam International Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adam International Hospital</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.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intima media thickness is increasingly used as a surrogate end point of vascular outcomes&#xD;
      in clinical trials aimed at determining the success of interventions that lower risk factors&#xD;
      for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral&#xD;
      artery diseases, like disease of cavernosal artery). The investigators hypothesized that the&#xD;
      IMT of cavernosal artery would add to the predictive value of vasculogenic erectile&#xD;
      dysfunction risk and outcomes. This study seeks to evaluate these hypotheses with our&#xD;
      experience, investigating the predictive accuracy of Cavernosal Doppler ultrasound findings&#xD;
      for discriminating patients with vasculogenic erectile dysfunction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">January 29, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>erectile dysfunction</measure>
    <time_frame>six months</time_frame>
    <description>intima media thickness</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Penile Duplex</arm_group_label>
    <description>Measuring intima media thickness</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Penile Duplex</intervention_name>
    <description>Measuring intima media thickness</description>
    <arm_group_label>Penile Duplex</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Erectile dysfunction pateints&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Erectile dysfunction patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Penile trauma.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adam International Hospital</investigator_affiliation>
    <investigator_full_name>Ahmad Raef Sadek</investigator_full_name>
    <investigator_title>Dr. Ahmad Raef</investigator_title>
  </responsible_party>
  <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>
    <ipd_description>Erectile dysfunction</ipd_description>
  </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/NCT03038659
org study id: 2018
nct id: NCT03038659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Erectile dysfunction.
The intima media thickness is increasingly used as a surrogate end point of vascular outcomes
      in clinical trials aimed at determining the success of interventions that lower risk factors
      for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral
      artery diseases, like disease of cavernosal artery). The investigators hypothesized that the
      IMT of cavernosal artery would add to the predictive value of vasculogenic erectile
      dysfunction risk and outcomes. This study seeks to evaluate these hypotheses with our
      experience, investigating the predictive accuracy of Cavernosal Doppler ultrasound findings
      for discriminating patients with vasculogenic erectile dysfunction.
observational model: Case-Control
time perspective: Prospective
measure: erectile dysfunction
time frame: six months
description: intima media thickness
arm group label: Penile Duplex
description: Measuring intima media thickness
intervention type: Device
intervention name: Penile Duplex
description: Measuring intima media thickness
arm group label: Penile Duplex
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Adam International Hospital
investigator full name: Ahmad Raef Sadek
investigator title: Dr. Ahmad Raef
mesh term: Erectile Dysfunction
sharing ipd: No
ipd description: Erectile dysfunction