<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/NCT03805087</url>
  </required_header>
  <id_info>
    <org_study_id>ICH-Emborrhoid</org_study_id>
    <nct_id>NCT03805087</nct_id>
  </id_info>
  <brief_title>Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids</brief_title>
  <official_title>Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humanitas Clinical and Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Humanitas Clinical and Research Center</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>
      This study will evaluate short , mid and long term efficacy of transarterial coil&#xD;
      embolization of the superior rectal arteries (Emborrhoid techinque) for treatment the&#xD;
      hemorrhoidal disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 'emborrhoid' technique is the embolization of the hemorrhoidal arteries. The endovascular&#xD;
      arterial occlusion is performed using coils placed in the terminal branches of the superior&#xD;
      rectal arteries The emborrhoid technique has been modeled after elective transanal&#xD;
      Doppler-guided hemorrhoidal artery ligation, which has been shown to be safe and effective&#xD;
      for hemorrhoidal disease.&#xD;
&#xD;
      To date, there are few reports regarding emborrhoid, particularly lacking in long-term&#xD;
      follow-up. Additionally, all procedures reported so far have used a transfemoral access&#xD;
      route, which requires at least one day of hospital stay.&#xD;
&#xD;
      The aims of this study are:&#xD;
&#xD;
      To increase data regarding safety and efficacy of the Emborrhoid technique To report changes&#xD;
      in the quality of life of patients at short and long-term To quantify recurrences at one-year&#xD;
      follow-up To validate the use of the radial access for the Emborrhoid technique To validate&#xD;
      the Emborrhoid technique as a &quot;one-day&quot; hospital procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the severity of symptoms of hemorrhoidal disease</measure>
    <time_frame>1 years</time_frame>
    <description>A symptom-based severity score (Sordegren scoring system) will be used before and after intervention. It is a questionnaire composed by 4 questions with a final scoring of 0-14 where 14 is the highest possible severity of symptoms.&#xD;
The questionnaire will be administered the day before procedure, one week after procedure and one year after procedure.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hemorrhoids</condition>
  <condition>Embolization, Therapeutic</condition>
  <arm_group>
    <arm_group_label>Coil embolization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transarterial coil embolization</intervention_name>
    <description>Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.</description>
    <arm_group_label>Coil embolization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with at least grade II Hemorrhoids (Banov et al. 1985), agreeing to undergo&#xD;
             the Embhorroid technique.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute contraindications to an angiographic procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>EZIO LANZA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>EZIO LANZA, MD</last_name>
    <phone>0282247383</phone>
    <email>eziolanza@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>EZIO LANZA, MD</last_name>
      <phone>3476247530</phone>
      <email>eziolanza@gmail.com</email>
    </contact>
    <investigator>
      <last_name>EZIO LANZA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>PAOLA CAMPENNI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Berczi V, Gopalan D, Cleveland TJ. Embolization of a hemorrhoid following 18 hours of life-threatening bleeding. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):183-5. doi: 10.1007/s00270-006-0179-4.</citation>
    <PMID>17334848</PMID>
  </results_reference>
  <results_reference>
    <citation>Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub 2014 Feb 28.</citation>
    <PMID>24589187</PMID>
  </results_reference>
  <results_reference>
    <citation>Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.</citation>
    <PMID>29724519</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemorrhoids</keyword>
  <keyword>Embolization, Therapeutic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03805087
org study id: ICH-Emborrhoid
nct id: NCT03805087
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate short , mid and long term efficacy of transarterial coil
      embolization of the superior rectal arteries (Emborrhoid techinque) for treatment the
      hemorrhoidal disease.
The 'emborrhoid' technique is the embolization of the hemorrhoidal arteries. The endovascular
      arterial occlusion is performed using coils placed in the terminal branches of the superior
      rectal arteries The emborrhoid technique has been modeled after elective transanal
      Doppler-guided hemorrhoidal artery ligation, which has been shown to be safe and effective
      for hemorrhoidal disease.

      To date, there are few reports regarding emborrhoid, particularly lacking in long-term
      follow-up. Additionally, all procedures reported so far have used a transfemoral access
      route, which requires at least one day of hospital stay.

      The aims of this study are:

      To increase data regarding safety and efficacy of the Emborrhoid technique To report changes
      in the quality of life of patients at short and long-term To quantify recurrences at one-year
      follow-up To validate the use of the radial access for the Emborrhoid technique To validate
      the Emborrhoid technique as a "one-day" hospital procedure
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in the severity of symptoms of hemorrhoidal disease
time frame: 1 years
description: A symptom-based severity score (Sordegren scoring system) will be used before and after intervention. It is a questionnaire composed by 4 questions with a final scoring of 0-14 where 14 is the highest possible severity of symptoms.
The questionnaire will be administered the day before procedure, one week after procedure and one year after procedure.
arm group label: Coil embolization
arm group type: Experimental
description: Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
intervention type: Procedure
intervention name: Transarterial coil embolization
description: Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
arm group label: Coil embolization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: EZIO LANZA, MD
role: Principal Investigator
affiliation: Humanitas Research Hospital
last name: EZIO LANZA, MD
phone: 0282247383
email: eziolanza@gmail.com
facility: 
contact: 
investigator: 
investigator: 
country: Italy
citation: Berczi V, Gopalan D, Cleveland TJ. Embolization of a hemorrhoid following 18 hours of life-threatening bleeding. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):183-5. doi: 10.1007/s00270-006-0179-4.
PMID: 17334848
citation: Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub 2014 Feb 28.
PMID: 24589187
citation: Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.
PMID: 29724519
responsible party type: Sponsor
mesh term: Hemorrhoids
sharing ipd: Undecided