<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/NCT03785665</url>
  </required_header>
  <id_info>
    <org_study_id>CL-MD1-01-0097</org_study_id>
    <nct_id>NCT03785665</nct_id>
  </id_info>
  <brief_title>Motility of the Check-cap's MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy</brief_title>
  <official_title>To Monitor the Whole Gut Transit Time and Repeatability of the Motility of MD1 Capsules in the Colon of Subjects With Known Polyps and in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Check-Cap Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Check-Cap Ltd.</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>
      To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in&#xD;
      the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home&#xD;
      Monitoring, Prospective Study. Up to 100 participants in various phases 2-5 capsules per&#xD;
      person, (1 capsule at a time) The primary objective of the study is to monitor the&#xD;
      variability of the motility of the MD1 capsules in the Gastrointestinal tract of human&#xD;
      subjects with and without polyps in previous Colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subject population in this study will be composed of male and female subjects older than&#xD;
      40 and younger than 80 years old who volunteer for the experiment and qualify with the&#xD;
      inclusion / exclusion criteria A total of one hundred (100) subjects will be enrolled in this&#xD;
      study. All study participants will be examined by the MD1 capsules, 2-5 capsules per person,&#xD;
      one capsule at a time. Efforts will be made to maintain balanced numbers between men and&#xD;
      women and even distribution of ages.&#xD;
&#xD;
      The study will be conducted by phases:&#xD;
&#xD;
      A 15-20 Men with polyps in previous Colonoscopy (2-3 repeated ingestions) B. 10-20 Men With&#xD;
      no polyps in previous Colonoscopy (1-2 repeated ingestions) C. 15-20 Women with polyps in&#xD;
      previous Colonoscopy (2-3 repeated ingestions) D. 10-20 Women With no polyps in previous&#xD;
      Colonoscopy (1-2 repeated ingestions) E Same as A-D with the use of prokinetic drugs F. Same&#xD;
      as A-D with different type of capsules (lower weight and/or rounded caps on both sides).&#xD;
&#xD;
      The total duration of the study for each subject is two-four weeks. Each subject will ingest&#xD;
      2-5 capsules, one at a time, with at least 1 week apart between repeated ingestion&#xD;
&#xD;
        1. st Visit (phone interview) - Each subject will receive a comprehensive explanation&#xD;
           regarding the study nature. During this process, and per ethical committee approval,&#xD;
           subjects may be asked several questions (over the phone) regarding their medical&#xD;
           background for preliminary assessment of eligibility.&#xD;
&#xD;
        2. nd Visit - Once informed consent is obtained, a thorough evaluation of subject's&#xD;
           eligibility will be performed based on inclusion / exclusion criteria.&#xD;
&#xD;
      Consent to participate in this study must be given in writing. The signed informed consent&#xD;
      will remain in subject's file. A signed copy will be given to the subject.&#xD;
&#xD;
      Subject will ingest the capsule (in the presence of a medical professional).&#xD;
&#xD;
      Post ingestion, the subject will receive detailed instructions about the daily routine and&#xD;
      activities and then will be discharged home with written instructions on the procedure (IFU -&#xD;
      Instructions for use). The subject should avoid intensive physical exercise during the&#xD;
      procedure or any extreme activities. The subject should make an effort to stay at home or&#xD;
      other familiar surroundings (within 2 hours of driving from the clinic), and may continue&#xD;
      daily activities such mobile/computer/TV (Television) use, shower, sleep or eat.&#xD;
&#xD;
      Details on allowed and restricted activities are listed in the Information For use which is&#xD;
      included in the Kit).&#xD;
&#xD;
      All subjects will be provided with a contact card with study details and site contact&#xD;
      information (24/7).&#xD;
&#xD;
      Discharged home&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2019</start_date>
  <completion_date type="Actual">January 11, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</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>
    <intervention_model_description>Multi-Center, Open, Home Monitoring, Prospective Study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the variability of the motility (Whole gut transit time from ingestion to excretion {hours}) of the MD1 (Motility dummy 1) capsules in the Gastrointestinal tract of human subjects with and w/out polyps in previous Colonoscopy.</measure>
    <time_frame>12 months</time_frame>
    <description>All participating subjects will be consented for multiple measurements. In selected subjects the experiment will be repeated with same type MD1 capsule but w/out the drug, to compare the effect of the drug on the motility and the instantaneous speed during contractions. These subjects will be selected according to their results in the first round, ease of adjustment to the monitoring routine, retrieval of the excreted capsules and lack of any side effects or complains.&#xD;
The repeated procedure will be at least 1 week apart and will be approved by the investigator only after positive identification of the excretion of the first capsule. Naturally, there is no need to repeat the colonoscopy procedure The repeated tests will be conducted according to the same protocol. There are no additional safety issues in the re-ingestions tests since the 1st capsule has to be excreted and retrieved few days before the repeated experiment starts</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Colo-rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MDI</intervention_name>
    <description>Capsule MD1 (Motility dummy 1)</description>
    <arm_group_label>Participants</arm_group_label>
    <other_name>Capsule MD1 (Motility dummy 1)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 40 and 80 years of age&#xD;
&#xD;
          -  Subjects which are generally healthy&#xD;
&#xD;
          -  Subjects who were examined by colonoscopy during the previous 5 years period and can&#xD;
             provide a copy of the report&#xD;
&#xD;
          -  Subjects who are ready to undergo the monitoring routine and commit to at least two&#xD;
             experiments&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with advanced cancer or other life threatening diseases or conditions&#xD;
&#xD;
          -  Subject with known history of dysphagia or other swallowing disorders&#xD;
&#xD;
          -  Subject with known history of Gastrointestinal disease or symptoms, such as: Crohn's&#xD;
             disease, Colitis, Inflammatory bowel disease (IBD), Meckel's Diverticulum, Bowen&#xD;
             Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).&#xD;
&#xD;
          -  Subject with known motility disorder or Chronic Constipation (less than 3 bowel&#xD;
             movements/week)&#xD;
&#xD;
          -  Subject with known delayed gastric emptying&#xD;
&#xD;
          -  Subject with prior history of abdominal surgery that might cause bowel strictures&#xD;
             leading to capsule retention, as determined by physician discretion&#xD;
&#xD;
          -  Subject with any condition believed to have an increased risk for capsule retention&#xD;
             such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to&#xD;
             obstructions or Nonsteroidal anti-inflammatory drugs (NSAID) enteropathy, as&#xD;
             determined by physician discretion&#xD;
&#xD;
          -  Subjects with known sensitivity to iodine, or with kidney failure&#xD;
&#xD;
          -  Subjects with morbid obesity (Body Mass Index &gt; 35)&#xD;
&#xD;
          -  Subjects with belly / girth circumference &gt; 125 cm&#xD;
&#xD;
          -  Subject with any known condition which precludes compliance with study and/or device&#xD;
             instructions&#xD;
&#xD;
          -  Subject with known condition of drug abuse and/or alcoholism&#xD;
&#xD;
          -  Women who are either pregnant or nursing at the time of screening (to be verified by&#xD;
             test in case of woman of child-bearing potential that do not practice medically&#xD;
             acceptable methods of contraception)&#xD;
&#xD;
          -  Concurrent participation in another clinical trial using any investigational drug or&#xD;
             device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boaz Shpigelman</last_name>
    <role>Study Director</role>
    <affiliation>VP R&amp;D</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bnai Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <state>North</state>
        <zip>33391</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>January 16, 2022</last_update_submitted>
  <last_update_submitted_qc>January 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</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 Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03785665
org study id: CL-MD1-01-0097
nct id: NCT03785665
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in
      the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home
      Monitoring, Prospective Study. Up to 100 participants in various phases 2-5 capsules per
      person, (1 capsule at a time) The primary objective of the study is to monitor the
      variability of the motility of the MD1 capsules in the Gastrointestinal tract of human
      subjects with and without polyps in previous Colonoscopy.
The subject population in this study will be composed of male and female subjects older than
      40 and younger than 80 years old who volunteer for the experiment and qualify with the
      inclusion / exclusion criteria A total of one hundred (100) subjects will be enrolled in this
      study. All study participants will be examined by the MD1 capsules, 2-5 capsules per person,
      one capsule at a time. Efforts will be made to maintain balanced numbers between men and
      women and even distribution of ages.

      The study will be conducted by phases:

      A 15-20 Men with polyps in previous Colonoscopy (2-3 repeated ingestions) B. 10-20 Men With
      no polyps in previous Colonoscopy (1-2 repeated ingestions) C. 15-20 Women with polyps in
      previous Colonoscopy (2-3 repeated ingestions) D. 10-20 Women With no polyps in previous
      Colonoscopy (1-2 repeated ingestions) E Same as A-D with the use of prokinetic drugs F. Same
      as A-D with different type of capsules (lower weight and/or rounded caps on both sides).

      The total duration of the study for each subject is two-four weeks. Each subject will ingest
      2-5 capsules, one at a time, with at least 1 week apart between repeated ingestion

        1. st Visit (phone interview) - Each subject will receive a comprehensive explanation
           regarding the study nature. During this process, and per ethical committee approval,
           subjects may be asked several questions (over the phone) regarding their medical
           background for preliminary assessment of eligibility.

        2. nd Visit - Once informed consent is obtained, a thorough evaluation of subject's
           eligibility will be performed based on inclusion / exclusion criteria.

      Consent to participate in this study must be given in writing. The signed informed consent
      will remain in subject's file. A signed copy will be given to the subject.

      Subject will ingest the capsule (in the presence of a medical professional).

      Post ingestion, the subject will receive detailed instructions about the daily routine and
      activities and then will be discharged home with written instructions on the procedure (IFU -
      Instructions for use). The subject should avoid intensive physical exercise during the
      procedure or any extreme activities. The subject should make an effort to stay at home or
      other familiar surroundings (within 2 hours of driving from the clinic), and may continue
      daily activities such mobile/computer/TV (Television) use, shower, sleep or eat.

      Details on allowed and restricted activities are listed in the Information For use which is
      included in the Kit).

      All subjects will be provided with a contact card with study details and site contact
      information (24/7).

      Discharged home
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Multi-Center, Open, Home Monitoring, Prospective Study
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measure the variability of the motility (Whole gut transit time from ingestion to excretion {hours}) of the MD1 (Motility dummy 1) capsules in the Gastrointestinal tract of human subjects with and w/out polyps in previous Colonoscopy.
time frame: 12 months
description: All participating subjects will be consented for multiple measurements. In selected subjects the experiment will be repeated with same type MD1 capsule but w/out the drug, to compare the effect of the drug on the motility and the instantaneous speed during contractions. These subjects will be selected according to their results in the first round, ease of adjustment to the monitoring routine, retrieval of the excreted capsules and lack of any side effects or complains.
The repeated procedure will be at least 1 week apart and will be approved by the investigator only after positive identification of the excretion of the first capsule. Naturally, there is no need to repeat the colonoscopy procedure The repeated tests will be conducted according to the same protocol. There are no additional safety issues in the re-ingestions tests since the 1st capsule has to be excreted and retrieved few days before the repeated experiment starts
arm group label: Participants
arm group type: Experimental
description: All study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages
intervention type: Device
intervention name: MDI
description: Capsule MD1 (Motility dummy 1)
arm group label: Participants
other name: Capsule MD1 (Motility dummy 1)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boaz Shpigelman
role: Study Director
affiliation: VP R&D
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Rectal Neoplasms