<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/NCT03017898</url>
  </required_header>
  <id_info>
    <org_study_id>FiLaC-2016</org_study_id>
    <nct_id>NCT03017898</nct_id>
  </id_info>
  <brief_title>Treatment of Anal Fistula With Lasercoagulation</brief_title>
  <official_title>Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</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 purpose of this study is to determine whether treatment with laser coagulation is an&#xD;
      effective and safe treatment option for patients with anal fistula&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment of anal fistula remains a challenge - the only truly effective treatment available&#xD;
      (fistulotomy) involves very high rates of anal incontinence if performed on the majority of&#xD;
      patients, and a vast number of alternative, sphincter-preserving treatments have been&#xD;
      developed and evaluated in the past decades. The treatment of anal fistula with laser&#xD;
      coagulation causes the fistula to collapse and subsequently heal, without having to add any&#xD;
      external materials. The available published studies show that the treatment is safe regarding&#xD;
      infection and incontinence, and that a majority of the patients treated show complete&#xD;
      healing. There is however a need for more prospective studies to ascertain these preliminary&#xD;
      facts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study halted due to lower success rates than expected, under evaluation, will potentially&#xD;
    resume at a later date.&#xD;
  </why_stopped>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Healing</measure>
    <time_frame>12 months</time_frame>
    <description>Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of fecal incontinence as described by the patient</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Fistula-In-Ano</condition>
  <condition>Anal Fistula</condition>
  <arm_group>
    <arm_group_label>Laser coagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of anal fistulae meeting the inclusion criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser Coagulation</intervention_name>
    <description>Laser coagulation of anal fistula</description>
    <arm_group_label>Laser coagulation</arm_group_label>
    <other_name>Fistula Laser Closure (FiLaC)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has been informed of the nature of the study, agrees to its provisions, and&#xD;
             has provided written informed consent.&#xD;
&#xD;
          2. Subject must be at least 18 years of age&#xD;
&#xD;
          3. Subject must have a verified anal fistula (by transanal ultrasound performed by&#xD;
             treating surgeon)&#xD;
&#xD;
          4. Subject must have a clean and infection-free fistula tract (no cavities seen on&#xD;
             transanal ultrasound)&#xD;
&#xD;
          5. Subject must be able to comply with study and study follow-up requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject with anorectal fistula due to Crohn's disease&#xD;
&#xD;
          2. Subject has an undrained abscess in fistula tract (cavities as seen on transanal&#xD;
             ultrasound)&#xD;
&#xD;
          3. Subject has fistula with side tracts (as seen on transanal ultrasound)&#xD;
&#xD;
          4. Subject is unable or unwilling to provide informed consent.&#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>Skåne University Hospital</name>
      <address>
        <city>Malmo</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16.</citation>
    <PMID>21845480</PMID>
  </reference>
  <reference>
    <citation>Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28.</citation>
    <PMID>25724967</PMID>
  </reference>
  <reference>
    <citation>Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser--FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014 Feb;16(2):110-5. doi: 10.1111/codi.12440.</citation>
    <PMID>24119103</PMID>
  </reference>
  <reference>
    <citation>Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067.</citation>
    <PMID>24509460</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FiLaC</keyword>
  <keyword>Fistula Laser Closure</keyword>
  <keyword>Laser Coagulation</keyword>
  <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>No</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/NCT03017898
org study id: FiLaC-2016
nct id: NCT03017898
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether treatment with laser coagulation is an
      effective and safe treatment option for patients with anal fistula
Treatment of anal fistula remains a challenge - the only truly effective treatment available
      (fistulotomy) involves very high rates of anal incontinence if performed on the majority of
      patients, and a vast number of alternative, sphincter-preserving treatments have been
      developed and evaluated in the past decades. The treatment of anal fistula with laser
      coagulation causes the fistula to collapse and subsequently heal, without having to add any
      external materials. The available published studies show that the treatment is safe regarding
      infection and incontinence, and that a majority of the patients treated show complete
      healing. There is however a need for more prospective studies to ascertain these preliminary
      facts.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Healing
time frame: 12 months
description: Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no).
measure: Infection
time frame: 12 months
description: Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment.
measure: Incontinence
time frame: 12 months
description: Presence of fecal incontinence as described by the patient
arm group label: Laser coagulation
arm group type: Experimental
description: Treatment of anal fistulae meeting the inclusion criteria
intervention type: Procedure
intervention name: Laser Coagulation
description: Laser coagulation of anal fistula
arm group label: Laser coagulation
other name: Fistula Laser Closure (FiLaC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
citation: Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16.
PMID: 21845480
citation: Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28.
PMID: 25724967
citation: Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser--FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014 Feb;16(2):110-5. doi: 10.1111/codi.12440.
PMID: 24119103
citation: Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067.
PMID: 24509460
responsible party type: Sponsor
mesh term: Rectal Fistula
mesh term: Fistula
sharing ipd: No