<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/NCT04461860</url>
  </required_header>
  <id_info>
    <org_study_id>SCVPC (29BRC20.0089)</org_study_id>
    <nct_id>NCT04461860</nct_id>
  </id_info>
  <brief_title>Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization</brief_title>
  <acronym>SCVPC</acronym>
  <official_title>Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Summary:&#xD;
&#xD;
      Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in&#xD;
      treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in&#xD;
      the University hospital of Brest.&#xD;
&#xD;
      The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous&#xD;
      scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The&#xD;
      Secondary Outcome Measures were to assess the impact of the treatment on specific and general&#xD;
      symptoms through a survey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A retrospective, non-invasive monocentric study of our Hospital 10-year registry (including&#xD;
      data on MRI angiography and Vascular Doppler Ultrasound) of patients who have already&#xD;
      undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion&#xD;
      syndrome. These patients will be contacted by phone to participate in the study. An&#xD;
      information letter will be handed out and the study protocol will be explained to the&#xD;
      patients. After obtaining their written consent, they will be asked to fill out the study's&#xD;
      validated questionnaire at home and return it to us through pre-paid regular mail. A face to&#xD;
      face interview with the patient will be scheduled to assess the correlation between patient's&#xD;
      clinical symptoms and survey results. There will be no change in patient's routine follow-up&#xD;
      care.&#xD;
&#xD;
      All physician investigators of the study are experts in their field of medicine (e.g.&#xD;
      interventional MRI angiography, vascular disease).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 21, 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic congestion pain relief</measure>
    <time_frame>pre-embolization and 1 month post-gonadal vein embolization</time_frame>
    <description>To evaluate (to measure) pain relief using visual analogous scale before and after gonadal vein embolization for pelvic congestion syndrome. A high score means a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey</measure>
    <time_frame>pre-embolization and 1 month post-gonadal vein embolization</time_frame>
    <description>to assess the impact of gonadal vein embolization on specific symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey</measure>
    <time_frame>pre-embolization and 1 month post-gonadal vein embolization</time_frame>
    <description>to assess the impact of gonadal vein embolization on general symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pelvic Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        women &gt; 18 years old with at least 1 previous pregnancy and delivery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler&#xD;
             ultrasound and vascular dynamic MRI&#xD;
&#xD;
          -  Failed medical treatment.&#xD;
&#xD;
          -  &gt; 18 years &lt; 60 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years old&#xD;
&#xD;
          -  Under legal guardian&#xD;
&#xD;
          -  Asymptomatic pelvic congestion syndrome&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  Endometriosis.&#xD;
&#xD;
          -  Chronic pelvic disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Neoplasia&#xD;
&#xD;
          -  Acute intermittent porphyria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Philippe QUEHE</last_name>
    <phone>02 98 34 75 45</phone>
    <email>philippe.quehe@chu-brest.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe QUEHE</last_name>
      <email>philippe.quehe@chu-brest.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>syndrome</keyword>
  <keyword>pain</keyword>
  <keyword>pelvic</keyword>
  <keyword>vein</keyword>
  <keyword>embolization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available beginning one year and ending five years following the end of the study</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
  </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/NCT04461860
org study id: SCVPC (29BRC20.0089)
nct id: NCT04461860
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Summary:

      Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in
      treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in
      the University hospital of Brest.

      The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous
      scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The
      Secondary Outcome Measures were to assess the impact of the treatment on specific and general
      symptoms through a survey.
A retrospective, non-invasive monocentric study of our Hospital 10-year registry (including
      data on MRI angiography and Vascular Doppler Ultrasound) of patients who have already
      undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion
      syndrome. These patients will be contacted by phone to participate in the study. An
      information letter will be handed out and the study protocol will be explained to the
      patients. After obtaining their written consent, they will be asked to fill out the study's
      validated questionnaire at home and return it to us through pre-paid regular mail. A face to
      face interview with the patient will be scheduled to assess the correlation between patient's
      clinical symptoms and survey results. There will be no change in patient's routine follow-up
      care.

      All physician investigators of the study are experts in their field of medicine (e.g.
      interventional MRI angiography, vascular disease).
observational model: Cohort
time perspective: Other
measure: Pelvic congestion pain relief
time frame: pre-embolization and 1 month post-gonadal vein embolization
description: To evaluate (to measure) pain relief using visual analogous scale before and after gonadal vein embolization for pelvic congestion syndrome. A high score means a worse outcome.
measure: evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey
time frame: pre-embolization and 1 month post-gonadal vein embolization
description: to assess the impact of gonadal vein embolization on specific symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.
measure: evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey
time frame: pre-embolization and 1 month post-gonadal vein embolization
description: to assess the impact of gonadal vein embolization on general symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Philippe QUEHE
phone: 02 98 34 75 45
email: philippe.quehe@chu-brest.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Pelvic Pain
sharing ipd: Yes
ipd info type: Study Protocol
ipd time frame: Data will be available beginning one year and ending five years following the end of the study
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.