<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/NCT03813251</url>
  </required_header>
  <id_info>
    <org_study_id>CD-14-002</org_study_id>
    <nct_id>NCT03813251</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)</brief_title>
  <official_title>Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ForConti Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ForConti Medical</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ForConti Contix Fecal Incontinence Management System (FIMS) is indicated for the&#xD;
      management of accidental bowel leakage due to bowel incontinence. The ForConti Contix FIMS is&#xD;
      designed to seal and help prevent the involuntary leakage of stool, liquids and gases from&#xD;
      the rectum. ForConti Contix FIMS is for an individual with fecal incontinence that has&#xD;
      impaired quality of life, is responsive and mentally capable to participate in their own&#xD;
      treatment.&#xD;
&#xD;
      This study is designed to evaluate the safety and effectiveness of the ForConti Contix FIMS&#xD;
      for its intended use utilizing a baseline period of 2 weeks followed by an on-device period&#xD;
      of using the device for 4 weeks and completed with a followup period of 2 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatments for bowel incontinence depend on the cause and severity of the condition. Often&#xD;
      more than one modality is used to treat the condition, beginning with conservative options&#xD;
      such as adult diapers and pads, medication, biofeedback and anal plugs/balloons and moving on&#xD;
      to invasive procedures (i.e. nerve stimulators, restorative surgery, colostomy) where&#xD;
      conservative treatment isn't effective.&#xD;
&#xD;
      The main reason for potential pain and discomfort with the current available anal plugs is&#xD;
      the plug location within the anus below the dentate line. This part of the anus, which is&#xD;
      highly sensitive, may cause discomfort and pain to some users. The advantage of the ForConti&#xD;
      Contix Fecal Incontinence Management System (FIMS) is that it is designed to be located in an&#xD;
      inner section of the rectum, above the dentate line, and therefore less sensitive and less&#xD;
      likely to cause discomfort or pain to the user.&#xD;
&#xD;
      This study is a prospective, non-randomized, single-arm, self-controlled clinical&#xD;
      investigation designed to evaluate the safety and effectiveness of the ForConti Contix FIMS.&#xD;
      Total duration of the study for each patient will be 8 weeks, including follow-up.&#xD;
&#xD;
      This multi center study will be conducted on 10-20 patients (per site) suffering from&#xD;
      accidental bowel leakage due to bowel incontinence and who meet all of the inclusion criteria&#xD;
      and none of the exclusion criteria.&#xD;
&#xD;
      The ForConti Contix FIMS includes 2 main parts: the inserted part and the insertion system.&#xD;
      The inserted part includes a balloon and a pulling string, and the insertion system includes&#xD;
      the applicator and the inflation kit. The balloon is a soft flexible biocompatible,&#xD;
      component. It is designed to be located in the rectum by an applicator and to be filled with&#xD;
      a pre-determined amount of air to gain its final shape.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>Number of device related serious adverse events</measure>
    <time_frame>6 weeks (4 weeks of use and 2 weeks follow-up)</time_frame>
    <description>Number of device related serious adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of subjects who improved by 50% or more in ABL (FI episodes) during the on-device period as compared to the baseline period.</measure>
    <time_frame>8 weeks (2 weeks baseline, 4 weeks of use and 2 weeks follow-up)</time_frame>
    <description>≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of device or procedure related adverse events in the treatment or in the follow-up periods.</measure>
    <time_frame>6 weeks (4 weeks of use and 2 weeks follow-up)</time_frame>
    <description>Rate of device or procedure related adverse events in the treatment or in the follow-up periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean scores on subject-reported outcomes related to symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire.</measure>
    <time_frame>6 weeks (2 weeks baseline, 4 weeks of use )</time_frame>
    <description>Fecal Incontinence Quality of Life scale (all subscale scores 1-4) Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. Scale scores are the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Assigned Interventions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ForConti Contix Fecal Incontinence Management System (FIMS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ForConti Contix Fecal Incontinence Management System (FIMS)</intervention_name>
    <description>Use the device for up to 12 hours per use for 4 weeks</description>
    <arm_group_label>Assigned Interventions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has signed the informed consent form and is willing to participate in the&#xD;
             clinical study. Patient has the ability to self-manage insertion and removal of the&#xD;
             device&#xD;
&#xD;
          2. Patient age is between 22 and 85 years old&#xD;
&#xD;
          3. Patient has history of fecal incontinence for at least 6 months&#xD;
&#xD;
          4. Patient has a minimum of four incontinence episodes during the 2-week baseline period&#xD;
&#xD;
          5. Patient colon surveillance complies with National Program/Guidelines for the Early&#xD;
             Detection of Colorectal Cancer&#xD;
&#xD;
          6. Patient comprehends study meaning and is capable of carrying out study duties&#xD;
&#xD;
          7. If the candidate is currently prescribed medication per os or per rectum for bowel&#xD;
             control, treatment has been administered for at least 4 weeks without a change in&#xD;
             treatment regimen or dose, and the candidate agrees to continue the treatment without&#xD;
             changes for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient had spinal cord injury or other major neurological diagnosis&#xD;
&#xD;
          2. Patient has known life threatening disease such as cancer, immune deficiency state&#xD;
&#xD;
          3. Patient has significant cardiac arrhythmia*&#xD;
&#xD;
          4. Patient has inflammatory bowel disease&#xD;
&#xD;
          5. Patient is on anti-coagulants and anti-platelets treatment, except Aspirin (low dose:&#xD;
             75-100 mg/day)&#xD;
&#xD;
          6. Patient has anorectal disease: perianal abscess, active fistula, fissure, hemorrhoids&#xD;
             grade 3 or 4, Pruritus ani or rectal bleeding*&#xD;
&#xD;
          7. Patient has a clinically significant abnormality as visualized by sigmoidoscopy at the&#xD;
             first visit&#xD;
&#xD;
          8. Patient has pre-existing rectal pain or rectal bleeding&#xD;
&#xD;
          9. Patient suffers from chronic pelvic pain&#xD;
&#xD;
         10. Patient had rectal surgery in the past 6 months&#xD;
&#xD;
         11. Patient has rectocele or other pelvic organ prolapse requiring surgery*&#xD;
&#xD;
         12. Patient has allergy to silicone or one of its components&#xD;
&#xD;
         13. Patient has significant medical condition which may interfere with study participation&#xD;
&#xD;
         14. Patient is currently participating in another clinical study.&#xD;
&#xD;
         15. Female patient is pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stacy B Menees, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan, Department of Medicine, Division of Gastroenterology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William D Chey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan, GI Physiology Laboratory</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lin Chang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>David Gefen School of Medicine at UCLA, Division of Digestive Diseases</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shay Leventhal Gabay, CA/RA Director</last_name>
    <phone>+972-4-647-2419</phone>
    <email>shay.leventhal@forconti-medical.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</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>Fecal Incontinence</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/NCT03813251
org study id: CD-14-002
nct id: NCT03813251
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The ForConti Contix Fecal Incontinence Management System (FIMS) is indicated for the
      management of accidental bowel leakage due to bowel incontinence. The ForConti Contix FIMS is
      designed to seal and help prevent the involuntary leakage of stool, liquids and gases from
      the rectum. ForConti Contix FIMS is for an individual with fecal incontinence that has
      impaired quality of life, is responsive and mentally capable to participate in their own
      treatment.

      This study is designed to evaluate the safety and effectiveness of the ForConti Contix FIMS
      for its intended use utilizing a baseline period of 2 weeks followed by an on-device period
      of using the device for 4 weeks and completed with a followup period of 2 weeks.
Treatments for bowel incontinence depend on the cause and severity of the condition. Often
      more than one modality is used to treat the condition, beginning with conservative options
      such as adult diapers and pads, medication, biofeedback and anal plugs/balloons and moving on
      to invasive procedures (i.e. nerve stimulators, restorative surgery, colostomy) where
      conservative treatment isn't effective.

      The main reason for potential pain and discomfort with the current available anal plugs is
      the plug location within the anus below the dentate line. This part of the anus, which is
      highly sensitive, may cause discomfort and pain to some users. The advantage of the ForConti
      Contix Fecal Incontinence Management System (FIMS) is that it is designed to be located in an
      inner section of the rectum, above the dentate line, and therefore less sensitive and less
      likely to cause discomfort or pain to the user.

      This study is a prospective, non-randomized, single-arm, self-controlled clinical
      investigation designed to evaluate the safety and effectiveness of the ForConti Contix FIMS.
      Total duration of the study for each patient will be 8 weeks, including follow-up.

      This multi center study will be conducted on 10-20 patients (per site) suffering from
      accidental bowel leakage due to bowel incontinence and who meet all of the inclusion criteria
      and none of the exclusion criteria.

      The ForConti Contix FIMS includes 2 main parts: the inserted part and the insertion system.
      The inserted part includes a balloon and a pulling string, and the insertion system includes
      the applicator and the inflation kit. The balloon is a soft flexible biocompatible,
      component. It is designed to be located in the rectum by an applicator and to be filled with
      a pre-determined amount of air to gain its final shape.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of device related serious adverse events
time frame: 6 weeks (4 weeks of use and 2 weeks follow-up)
description: Number of device related serious adverse events
measure: Rate of subjects who improved by 50% or more in ABL (FI episodes) during the on-device period as compared to the baseline period.
time frame: 8 weeks (2 weeks baseline, 4 weeks of use and 2 weeks follow-up)
description: ≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period.
measure: Rate of device or procedure related adverse events in the treatment or in the follow-up periods.
time frame: 6 weeks (4 weeks of use and 2 weeks follow-up)
description: Rate of device or procedure related adverse events in the treatment or in the follow-up periods.
measure: Change in mean scores on subject-reported outcomes related to symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire.
time frame: 6 weeks (2 weeks baseline, 4 weeks of use )
description: Fecal Incontinence Quality of Life scale (all subscale scores 1-4) Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. Scale scores are the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale.
arm group label: Assigned Interventions
arm group type: Experimental
description: ForConti Contix Fecal Incontinence Management System (FIMS)
intervention type: Device
intervention name: ForConti Contix Fecal Incontinence Management System (FIMS)
description: Use the device for up to 12 hours per use for 4 weeks
arm group label: Assigned Interventions
criteria: 
gender: All
minimum age: 22 Years
maximum age: 85 Years
healthy volunteers: No
last name: Stacy B Menees, MD
role: Principal Investigator
affiliation: University of Michigan, Department of Medicine, Division of Gastroenterology
last name: William D Chey, MD
role: Principal Investigator
affiliation: University of Michigan, GI Physiology Laboratory
last name: Lin Chang, MD
role: Principal Investigator
affiliation: David Gefen School of Medicine at UCLA, Division of Digestive Diseases
last name: Shay Leventhal Gabay, CA/RA Director
phone: +972-4-647-2419
email: shay.leventhal@forconti-medical.com
responsible party type: Sponsor
mesh term: Fecal Incontinence
sharing ipd: No