<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/NCT03252041</url>
  </required_header>
  <id_info>
    <org_study_id>MRI &amp; MRV in PCS</org_study_id>
    <nct_id>NCT03252041</nct_id>
  </id_info>
  <brief_title>MRI &amp; MRV in Pelvic Congestion Syndrome in Females</brief_title>
  <acronym>PCS</acronym>
  <official_title>MRI &amp; MRV in Pelvic Congestion Syndrome in Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment&#xD;
      options and a lack of available resources. Their physicians were likewise perplexed, despite&#xD;
      the endless acquisition of negative laboratory and imaging data as well as inconclusive&#xD;
      consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased&#xD;
      physician awareness have lessened the confusion surrounding this condition and its distinct&#xD;
      association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and&#xD;
      minimally invasive surgical solutions give affected patients more therapeutic choices today.&#xD;
&#xD;
      Since anatomical venous variations in the pelvis are common, it is important to know the&#xD;
      anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of&#xD;
      pelvic varices, both to differentiate them from other condition and also because pelvic&#xD;
      varices may be secondary to serious underlying pathology, such as inferior vena caval&#xD;
      obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.&#xD;
&#xD;
      The diagnosis of PCS has usually been suggested by duplex ultrasound (US), but ultrasound&#xD;
      imaging does not readily show the gonadal veins. Phlebography is the &quot;gold standard&quot; for&#xD;
      anatomic diagnostic studies. Related mortality and morbidity are low, but patient discomfort&#xD;
      and costs make this an unattractive routine method of diagnosis. Magnetic resonance imaging&#xD;
      (MRI) can usually demonstrate pelvic and ovarian varices, as well as the gonadal veins.&#xD;
&#xD;
      In this prospective study, we will investigate the feasibility of using magnetic resonance&#xD;
      venography (MRV) in the diagnosis of PCS and evaluated its accuracy and reliability in&#xD;
      comparison to phlebography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MRI and MRV in pelvic congestion syndrome in females.</measure>
    <time_frame>one year</time_frame>
    <description>To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.</description>
  </primary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Pelvic Pain Syndrome</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Magnetic Resonance imaging modalities and sequences in pelvic congestion syndrome</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with signs and symptoms of PCS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with general contraindications to MRI as presence of any para-magnetic&#xD;
             substance as pacemakers, or in severely ill patients or those with claustrophobia,&#xD;
             arrhythmic patients.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.</gender_description>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hossam Galal, ass prof</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University, Egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed Sayed, (M.B.B.CH)</last_name>
    <phone>+201008253457</phone>
    <email>dr.abudeif@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Noha Attia, lect</last_name>
    <phone>+201001238435</phone>
    <email>nohamohamedali@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed AbuDeif Sayed</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>PCS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>to be shared when finished</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/NCT03252041
org study id: MRI & MRV in PCS
nct id: NCT03252041
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.
In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment
      options and a lack of available resources. Their physicians were likewise perplexed, despite
      the endless acquisition of negative laboratory and imaging data as well as inconclusive
      consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased
      physician awareness have lessened the confusion surrounding this condition and its distinct
      association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and
      minimally invasive surgical solutions give affected patients more therapeutic choices today.

      Since anatomical venous variations in the pelvis are common, it is important to know the
      anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of
      pelvic varices, both to differentiate them from other condition and also because pelvic
      varices may be secondary to serious underlying pathology, such as inferior vena caval
      obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

      The diagnosis of PCS has usually been suggested by duplex ultrasound (US), but ultrasound
      imaging does not readily show the gonadal veins. Phlebography is the "gold standard" for
      anatomic diagnostic studies. Related mortality and morbidity are low, but patient discomfort
      and costs make this an unattractive routine method of diagnosis. Magnetic resonance imaging
      (MRI) can usually demonstrate pelvic and ovarian varices, as well as the gonadal veins.

      In this prospective study, we will investigate the feasibility of using magnetic resonance
      venography (MRV) in the diagnosis of PCS and evaluated its accuracy and reliability in
      comparison to phlebography.
observational model: Cohort
time perspective: Prospective
measure: MRI and MRV in pelvic congestion syndrome in females.
time frame: one year
description: To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.
intervention type: Device
intervention name: MRI
description: Magnetic Resonance imaging modalities and sequences in pelvic congestion syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: No
last name: Hossam Galal, ass prof
role: Study Chair
affiliation: Assiut University, Egypt
last name: Mohamed Sayed, (M.B.B.CH)
phone: +201008253457
email: dr.abudeif@gmail.com
last name: Noha Attia, lect
phone: +201001238435
email: nohamohamedali@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed AbuDeif Sayed
investigator title: Dr
mesh term: Syndrome
mesh term: Pelvic Pain
sharing ipd: Undecided
ipd description: to be shared when finished