<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/NCT03297138</url>
  </required_header>
  <id_info>
    <org_study_id>FILAC</org_study_id>
    <nct_id>NCT03297138</nct_id>
  </id_info>
  <brief_title>Fistula Laser Closure</brief_title>
  <official_title>Fistula Laser Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      The anal complex fistula constitutes a challenge in proctologic surgery because of the of its&#xD;
      therapeutic care complexity due to the frequency of recurrences and the necessity to protect&#xD;
      the sphincter function.&#xD;
&#xD;
      For several years,differents techniques were developed &quot;said sphincter sparing techniques&quot; to&#xD;
      handle fistulas at risk on the anal continence.&#xD;
&#xD;
      Recently there is one of them , named FiLAC using a clip system not yet evaluated.&#xD;
&#xD;
      The purpose is to assess the success rate of his new surgery technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>surgery success rate</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Fistula;Rectal</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FiLAC laser</intervention_name>
    <description>The technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient having a surgical indication using FiLAC laser technique&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with anal fistula drained at least 3 months before inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fistula not well drained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Fistula</mesh_term>
    <mesh_term>Fistula</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/NCT03297138
org study id: FILAC
nct id: NCT03297138
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The anal complex fistula constitutes a challenge in proctologic surgery because of the of its
      therapeutic care complexity due to the frequency of recurrences and the necessity to protect
      the sphincter function.

      For several years,differents techniques were developed "said sphincter sparing techniques" to
      handle fistulas at risk on the anal continence.

      Recently there is one of them , named FiLAC using a clip system not yet evaluated.

      The purpose is to assess the success rate of his new surgery technique.
observational model: Cohort
time perspective: Retrospective
measure: surgery success rate
time frame: 6 months
intervention type: Procedure
intervention name: FiLAC laser
description: The technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Rectal Fistula
mesh term: Fistula
sharing ipd: Undecided