<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/NCT04441957</url>
  </required_header>
  <id_info>
    <org_study_id>20140456</org_study_id>
    <nct_id>NCT04441957</nct_id>
  </id_info>
  <brief_title>MechanO-Chemical Ablation Versus CompreSSion</brief_title>
  <acronym>MOCASS</acronym>
  <official_title>Endovenous MechanO-Chemical Ablation Plus Compression Versus CompreSSion Alone in Chronic Venous Ulcers Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Belarusian State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Belarusian State Medical 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>
      This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in&#xD;
      addition to multilayer elastic compression bandaging vs multilayer elastic compression&#xD;
      bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers&#xD;
      (VU's).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most severe form of chronic venous disease is venous ulceration with an overall&#xD;
      prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of&#xD;
      life, and their treatment places a heavy financial burden upon healthcare systems.&#xD;
&#xD;
      To get the ulcer to heal, the current best treatment is to wear a compression bandage with&#xD;
      multiple layers, with which about 60% of these ulcers will heal within 6 months.&#xD;
&#xD;
      There is evidence that treatment of the varicose veins by sahenous veins stripping will&#xD;
      prevent the ulcer recurrence.&#xD;
&#xD;
      Recent studies have suggested that novel proceduress of superficial truncal reflux&#xD;
      elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or&#xD;
      radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and&#xD;
      increase recurrence-free rate. These techniques can be carried out in the outpatient setting&#xD;
      and are much better tolerated by patients in comparison to surgery.&#xD;
&#xD;
      At the same time, no studies which compared compression plus endovenous mechanochemical&#xD;
      ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date.&#xD;
&#xD;
      The aim of this study is to see whether treatment of varicose veins using MOCA helps with&#xD;
      healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</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>Number of Participants with varicose Veins from absent (score 0) to severe (score 3).</measure>
    <time_frame>6-12 months</time_frame>
    <description>None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).</measure>
    <time_frame>6-12 months</time_frame>
    <description>None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with induration from absent (score 0) to severe (score 3).</measure>
    <time_frame>6-12 months</time_frame>
    <description>None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with active ulcers from absent (score 0) to severe (score 3).</measure>
    <time_frame>6-12 months</time_frame>
    <description>None (0), 1 (1), 2 (2), more than 2 (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).</measure>
    <time_frame>6-12 months</time_frame>
    <description>None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1)</measure>
    <time_frame>3-24 months</time_frame>
    <description>None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Varicose Veins</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Group A, MOCA-group</arm_group_label>
    <description>Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B, Elastic Compression only group</arm_group_label>
    <description>Treatment: Elastic Compression only</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovenous Mechano- Chemical Ablation</intervention_name>
    <description>The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.</description>
    <arm_group_label>Group A, MOCA-group</arm_group_label>
    <other_name>MOCA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with GSV incompetence and C6 were included in in the prospective consecutive case&#xD;
        study if they satisfied the selection criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient age &gt; 18 years.&#xD;
&#xD;
          2. Current leg ulceration of greater than 6 weeks.&#xD;
&#xD;
          3. Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.&#xD;
&#xD;
          4. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological&#xD;
             (CEAP) classification, clinical class C6.&#xD;
&#xD;
          5. Able to give informed consent to participate in the study after reading the patient&#xD;
             information documentation.&#xD;
&#xD;
          6. Ankle Brachial Pressure Index (ABPI) ≥ 0.8.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Postoperative varicose veins disease recurrence.&#xD;
&#xD;
          2. Patients who are unable to tolerate any multilayer compression bandaging / stockings&#xD;
             will be excluded.&#xD;
&#xD;
          3. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous&#xD;
             thrombosis or postthrombotic syndrome.&#xD;
&#xD;
          4. History of pulmonary embolism or stroke.&#xD;
&#xD;
          5. Current anticoagulation therapy (within 7 days of enrollment).&#xD;
&#xD;
          6. Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vladimir MD Khryshchanovich, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Educational Institution &quot;Belarusian State Medical University&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vladimir MD Khryshchanovich, Prof</last_name>
    <phone>+375296245578</phone>
    <email>vladimirkh77@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert MD Proczka</last_name>
    <phone>+37548601332752</phone>
    <email>ramjup@icloud.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Educational Institution &quot;Belarusian State Medical University&quot;</name>
      <address>
        <city>Minsk</city>
        <state>Dzerzhinski Ave., 83,</state>
        <zip>220116</zip>
        <country>Belarus</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Varvara Boika</last_name>
      <phone>+ 375 17 277-16-72</phone>
      <email>intdept@bsmu.by</email>
    </contact>
  </location>
  <location_countries>
    <country>Belarus</country>
  </location_countries>
  <reference>
    <citation>Kanchanabat B, Stapanavatr W, Kanchanasuttiruk P. Total superficial vein reflux eradication in the treatment of venous ulcer. World J Surg. 2015 May;39(5):1301-5. doi: 10.1007/s00268-014-2935-y.</citation>
    <PMID>25680797</PMID>
  </reference>
  <reference>
    <citation>Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.</citation>
    <PMID>15183623</PMID>
  </reference>
  <reference>
    <citation>Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.</citation>
    <PMID>29688123</PMID>
  </reference>
  <reference>
    <citation>Sullivan LP, Quach G, Chapman T. Retrograde mechanico-chemical endovenous ablation of infrageniculate great saphenous vein for persistent venous stasis ulcers. Phlebology. 2014 Dec;29(10):654-7. doi: 10.1177/0268355513501301. Epub 2013 Aug 22.</citation>
    <PMID>23969489</PMID>
  </reference>
  <reference>
    <citation>Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012 Mar;27(2):67-72. doi: 10.1258/phleb.2011.010100. Epub 2011 Jul 29.</citation>
    <PMID>21803800</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>November 13, 2021</last_update_submitted>
  <last_update_submitted_qc>November 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Belarusian State Medical University</investigator_affiliation>
    <investigator_full_name>Vladimir Khryshchanovich</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>VV</keyword>
  <keyword>MOCA</keyword>
  <keyword>GSV</keyword>
  <keyword>Venous Ulcers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>12.2021</ipd_time_frame>
    <ipd_access_criteria>To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).</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/NCT04441957
org study id: 20140456
nct id: NCT04441957
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in
      addition to multilayer elastic compression bandaging vs multilayer elastic compression
      bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers
      (VU's).
The most severe form of chronic venous disease is venous ulceration with an overall
      prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of
      life, and their treatment places a heavy financial burden upon healthcare systems.

      To get the ulcer to heal, the current best treatment is to wear a compression bandage with
      multiple layers, with which about 60% of these ulcers will heal within 6 months.

      There is evidence that treatment of the varicose veins by sahenous veins stripping will
      prevent the ulcer recurrence.

      Recent studies have suggested that novel proceduress of superficial truncal reflux
      elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or
      radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and
      increase recurrence-free rate. These techniques can be carried out in the outpatient setting
      and are much better tolerated by patients in comparison to surgery.

      At the same time, no studies which compared compression plus endovenous mechanochemical
      ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date.

      The aim of this study is to see whether treatment of varicose veins using MOCA helps with
      healing.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
time frame: 6-12 months
description: None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
measure: Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
time frame: 6-12 months
description: None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
measure: Number of Participants with induration from absent (score 0) to severe (score 3).
time frame: 6-12 months
description: None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
measure: Number of Participants with active ulcers from absent (score 0) to severe (score 3).
time frame: 6-12 months
description: None (0), 1 (1), 2 (2), more than 2 (3)
measure: Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
time frame: 6-12 months
description: None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
measure: Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1)
time frame: 3-24 months
description: None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)
arm group label: Group A, MOCA-group
description: Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression
arm group label: Group B, Elastic Compression only group
description: Treatment: Elastic Compression only
intervention type: Device
intervention name: Endovenous Mechano- Chemical Ablation
description: The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.
arm group label: Group A, MOCA-group
other name: MOCA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Vladimir MD Khryshchanovich, Prof
role: Study Chair
affiliation: Educational Institution "Belarusian State Medical University"
last name: Vladimir MD Khryshchanovich, Prof
phone: +375296245578
email: vladimirkh77@mail.ru
last name: Robert MD Proczka
phone: +37548601332752
email: ramjup@icloud.com
facility: 
status: Recruiting
contact: 
country: Belarus
citation: Kanchanabat B, Stapanavatr W, Kanchanasuttiruk P. Total superficial vein reflux eradication in the treatment of venous ulcer. World J Surg. 2015 May;39(5):1301-5. doi: 10.1007/s00268-014-2935-y.
PMID: 25680797
citation: Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
PMID: 15183623
citation: Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.
PMID: 29688123
citation: Sullivan LP, Quach G, Chapman T. Retrograde mechanico-chemical endovenous ablation of infrageniculate great saphenous vein for persistent venous stasis ulcers. Phlebology. 2014 Dec;29(10):654-7. doi: 10.1177/0268355513501301. Epub 2013 Aug 22.
PMID: 23969489
citation: Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012 Mar;27(2):67-72. doi: 10.1258/phleb.2011.010100. Epub 2011 Jul 29.
PMID: 21803800
responsible party type: Principal Investigator
investigator affiliation: Belarusian State Medical University
investigator full name: Vladimir Khryshchanovich
investigator title: Professor
mesh term: Varicose Veins
sharing ipd: Yes
ipd description: To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 12.2021
ipd access criteria: To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).