<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/NCT04494568</url>
  </required_header>
  <id_info>
    <org_study_id>HIFU-F-20.01</org_study_id>
    <nct_id>NCT04494568</nct_id>
  </id_info>
  <brief_title>Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis</brief_title>
  <acronym>ENDO-HIFU-R1</acronym>
  <official_title>Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EDAP TMS S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EDAP TMS S.A.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter&#xD;
      quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative&#xD;
      procedure using a high-intensity ultrasound probe to induce tissue devitalization using&#xD;
      acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is&#xD;
      validated to treat prostatic cancer.&#xD;
&#xD;
      The primary objective of this clinical investigation is to evaluate the safety of the HIFU&#xD;
      treatment of rectal endometriosis with Focal One® HIFU device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Actual">November 30, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</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>
    <intervention_model_description>INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the tolerance of rectal endometriosis treatment with HIFU</measure>
    <time_frame>6 months</time_frame>
    <description>The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the gynecological symptoms evolution of patients after HIFU treatment</measure>
    <time_frame>at 1 month, 3 months and 6 months post-intervention</time_frame>
    <description>EVA symptom Questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the of quality of life evolution of patients after HIFU treatment</measure>
    <time_frame>at 1 month, 3 months and 6 months post-intervention,</time_frame>
    <description>Quality of life questionnaire : MOS- SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the evolution of the nodule's volume</measure>
    <time_frame>at 6 months</time_frame>
    <description>The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the post-intervention analgesic treatment</measure>
    <time_frame>during the fisrt 10 days post treatment.</time_frame>
    <description>The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the digestive symptoms evolution of patients after HIFU treatment</measure>
    <time_frame>at 1 month, 3 months and 6 months post-intervention</time_frame>
    <description>Wexner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the digestive symptoms evolution of patients after HIFU treatment</measure>
    <time_frame>at 1 month, 3 months and 6 months post-intervention</time_frame>
    <description>Kess questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the sexual symptoms evolution of patients after HIFU treatment</measure>
    <time_frame>at 1 month, 3 months and 6 months post-intervention</time_frame>
    <description>SFSI questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the urinary symptoms evolution of patients after HIFU treatment</measure>
    <time_frame>at 1 month, 3 months and 6 months post-intervention</time_frame>
    <description>USP questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Endometriosis, Rectum</condition>
  <arm_group>
    <arm_group_label>HIFU intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will benefit of an HIFU Treatment of their rectal endometriosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HIFU treatment</intervention_name>
    <description>HIFU Treatment of rectal endometriosis</description>
    <arm_group_label>HIFU intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged at least 25 years-old&#xD;
&#xD;
          -  Rectal endometriosis in preoperative imaging, without other digestive locations&#xD;
             (colon, ileum and small intentine)&#xD;
&#xD;
          -  Symptomatic patient refusing hormonal treatment and/or surgery.&#xD;
&#xD;
          -  Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium&#xD;
             MRI and difusion sequence (according to standardized protocol)&#xD;
&#xD;
          -  Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the&#xD;
             probe in front of the rectal nodule)&#xD;
&#xD;
          -  Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with&#xD;
             intra-rectal contrast)&#xD;
&#xD;
          -  No curent pregnancy (negative BHCG &lt;72h before the HIFU procedure) and no pregnancy&#xD;
             project within 6 months after the HIFU procedure (post-treatment MRI delay)&#xD;
&#xD;
          -  Patient agreeing not to change her hormone treatment for the duration of the study.&#xD;
&#xD;
          -  Patient accepting the study constraints&#xD;
&#xD;
          -  Health insurance affiliated patient or beneficiary of an equivalent coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Virgin patient&#xD;
&#xD;
          -  Ongoing uro-genital infection&#xD;
&#xD;
          -  Anorectal anatomy incompatible with HIFU therapy&#xD;
&#xD;
          -  History of segmental rectal resection with mechanical anastomosis, shaving or discoid&#xD;
             resection&#xD;
&#xD;
          -  Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE®&#xD;
             contraceptive implants).&#xD;
&#xD;
          -  Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)&#xD;
&#xD;
          -  Latex allergy&#xD;
&#xD;
          -  Patient with contraindications to MRI&#xD;
&#xD;
          -  Patient with contraindications to Gadolinium injection&#xD;
&#xD;
          -  Patient previously treated with HIFU for a rectal endometriotic lesion&#xD;
&#xD;
          -  Patient not speaking nor reading French&#xD;
&#xD;
          -  Patient deprived of liberty following a legal or administrative decision&#xD;
&#xD;
          -  Patient under guardianship or tutelage measure&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gil DUBERNARD, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Tivoli-Ducos</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital BICETRE</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de Gynécologie</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rectal endometriosis, HIFU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04494568
org study id: HIFU-F-20.01
nct id: NCT04494568
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter
      quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative
      procedure using a high-intensity ultrasound probe to induce tissue devitalization using
      acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is
      validated to treat prostatic cancer.

      The primary objective of this clinical investigation is to evaluate the safety of the HIFU
      treatment of rectal endometriosis with Focal One® HIFU device.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the tolerance of rectal endometriosis treatment with HIFU
time frame: 6 months
description: The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
measure: Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
time frame: at 1 month, 3 months and 6 months post-intervention
description: EVA symptom Questionnaires
measure: Evaluation of the of quality of life evolution of patients after HIFU treatment
time frame: at 1 month, 3 months and 6 months post-intervention,
description: Quality of life questionnaire : MOS- SF-36
measure: Evaluation of the evolution of the nodule's volume
time frame: at 6 months
description: The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
measure: Evaluation of the post-intervention analgesic treatment
time frame: during the fisrt 10 days post treatment.
description: The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
measure: Evaluation of the digestive symptoms evolution of patients after HIFU treatment
time frame: at 1 month, 3 months and 6 months post-intervention
description: Wexner
measure: Evaluation of the digestive symptoms evolution of patients after HIFU treatment
time frame: at 1 month, 3 months and 6 months post-intervention
description: Kess questionnaires
measure: Evaluation of the sexual symptoms evolution of patients after HIFU treatment
time frame: at 1 month, 3 months and 6 months post-intervention
description: SFSI questionnaire
measure: Evaluation of the urinary symptoms evolution of patients after HIFU treatment
time frame: at 1 month, 3 months and 6 months post-intervention
description: USP questionnaire
arm group label: HIFU intervention
arm group type: Experimental
description: patients will benefit of an HIFU Treatment of their rectal endometriosis
intervention type: Device
intervention name: HIFU treatment
description: HIFU Treatment of rectal endometriosis
arm group label: HIFU intervention
criteria: 
gender: Female
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Gil DUBERNARD, Pr
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Endometriosis