<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/NCT03301909</url>
  </required_header>
  <id_info>
    <org_study_id>MDT16024</org_study_id>
    <nct_id>NCT03301909</nct_id>
  </id_info>
  <brief_title>Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers (&quot;HEIGHT&quot; Study)</brief_title>
  <official_title>Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers (&quot;HEIGHT&quot; Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</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>
      This is a feasibility, prospective, single center, open label, uncontrolled clinical study,&#xD;
      to evaluate the safety and preliminary efficacy of the different R&amp;D changes made and&#xD;
      implemented in the existing PillCam Capsule products family, PillCam Endoscopy System&#xD;
      subunits, the Patency system and bowel preparation procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of a screening - enrollment phase, a possible preparation phase followed&#xD;
      by the PillCam Endoscopy or Patency procedure visit and a post procedure telephone, follow up&#xD;
      visit.&#xD;
&#xD;
      Subjects may be assigned to any of the sub-assays done within this study as long as they&#xD;
      fulfill all the inclusion and exclusion criteria and depends on their availability and their&#xD;
      willingness to participate in a specific sub-assay.&#xD;
&#xD;
      Each subject may participate in up to 15 sub-assays during his/her participation in the&#xD;
      study, each ingestion will be separated in between by at least two weeks interval. A&#xD;
      following capsule may be ingested only upon verification of previous capsule excretion.&#xD;
      Subjects can participate in a specific sub-assay only once.&#xD;
&#xD;
      In general, under the study protocol, per a single procedure, each subject will undergo a&#xD;
      possible preparation phase followed by the PillCam endoscopy or Patency procedure and&#xD;
      telephone follow up visit. Overall the expected duration for subject's participation in the&#xD;
      study is expected to be up to 10 years, until subject will complete participation in up to 15&#xD;
      sub-assays.&#xD;
&#xD;
      Subject may withdraw consent at any time and will be considered as completed once completed&#xD;
      at least one capsule ingestion (PillCam or Patency) or completed one of the possible&#xD;
      procedures which are not involving capsule ingestion during the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2028</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All device related Adverse events will be collected and reported in order to assess the device safety.</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>All device related Adverse events will be reported by number, type, seriousness, severity and duration. All device related adverse events will be captured, regardless of severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of raw data generation in the data recorder by confirming presence of the procedure raw data output files (technical outcome)</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>A PillCam procedure will be assessed for raw data generation in the data recorder (similar to standard of care procedure), by confirming presence of the procedure output files (technical outcome). A nominal scale of Yes/No will be used to determine whether the raw data has been generated by the data recorder or not.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PillCam™ Endoscopy System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PillCam™ Endoscopy System consists of the following subunits:&#xD;
PillCam™ Capsule products' family:&#xD;
PillCam™ COLON 2&#xD;
PillCam™ UGI (upper gastrointestinal)&#xD;
PillCam™ SB3 (small bowel 3)&#xD;
PillCam™ Crohn's capsule&#xD;
Patency capsule: PillCam™ Patency capsule&#xD;
All the bellow system subunits are part of the Pillcam™ systems:&#xD;
PillCam™ Recorder&#xD;
PillCam™ Sensor Arrays &amp; Sensor Belt&#xD;
PillCam™ Software v. 9&#xD;
Workstation unit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PillCam™ Endoscopy System</intervention_name>
    <description>Subject may be assigned to any procedure involving modification of any of the PillCam™ Endoscopy System component as listed in the arm description.</description>
    <arm_group_label>PillCam™ Endoscopy System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bowel prep combination</intervention_name>
    <description>Subject may be assigned to any bowel preparation combination.</description>
    <arm_group_label>PillCam™ Endoscopy System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject either male or female is 45-85 years of age.&#xD;
&#xD;
          2. The subject is in good general health to enable participation in the study.&#xD;
&#xD;
          3. The subject received an explanation and understands the nature of the study and agrees&#xD;
             to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has dysphagia or any swallowing disorder.&#xD;
&#xD;
          2. Subject is known or is suspected to suffer from intestinal obstruction or stricture&#xD;
             (symptoms such as severe abdominal pain with accompanying nausea or vomiting).&#xD;
&#xD;
          3. Subject with known gastrointestinal motility disorders.&#xD;
&#xD;
          4. Subjects with known or suspected delayed gastric emptying.&#xD;
&#xD;
          5. Subject has known or suspected Crohn's disease, other inflammatory bowel disease,&#xD;
             perforations or structural disorders of the gut wall.&#xD;
&#xD;
          6. Subject has diabetes.&#xD;
&#xD;
          7. Subject has undergone certain prior abdominal surgery of the gastrointestinal tract,&#xD;
             (other than uncomplicated appendectomy or uncomplicated cholecystectomy) which may&#xD;
             interfere with the study, such as small bowel or colonic resection. This will be&#xD;
             evaluated by the investigator.&#xD;
&#xD;
          8. Subject has any allergy or other contraindication to any materials including&#xD;
             preparation used prior, during or after capsule endoscopy in the study.&#xD;
&#xD;
          9. Subject is expected to undergo MRI examination within 7 days after ingestion of the&#xD;
             capsule.&#xD;
&#xD;
         10. Subject has severe congestive heart failure or known renal or hepatic insufficiency.&#xD;
&#xD;
         11. Subject has a cardiac pacemakers or other implanted electromedical devices.&#xD;
&#xD;
         12. Subject has any condition, which according to the investigators judgment, precludes&#xD;
             compliance with study and/or device instructions.&#xD;
&#xD;
         13. Females who are pregnant or nursing at the time of screening and/or during the study&#xD;
             period, or are of child bearing potential without medically acceptable methods of&#xD;
             contraception.&#xD;
&#xD;
         14. Subject is currently participating in another clinical study that may directly or&#xD;
             indirectly affect the results of this study.&#xD;
&#xD;
         15. Subject is considered to be part of a vulnerable population (e.g. prisoners or those&#xD;
             without sufficient mental capacity).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wisam Sbeit, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Galil MC, Nahariya</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luba Klein</last_name>
    <phone>+972-54-2580211</phone>
    <email>luba.klein@medtronic.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medtronic - Glilee Medical Center</name>
      <address>
        <city>Yoqne'am 'Illit</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wisam Sbeit, M.D</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>November 11, 2022</last_update_submitted>
  <last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03301909
org study id: MDT16024
nct id: NCT03301909
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a feasibility, prospective, single center, open label, uncontrolled clinical study,
      to evaluate the safety and preliminary efficacy of the different R&D changes made and
      implemented in the existing PillCam Capsule products family, PillCam Endoscopy System
      subunits, the Patency system and bowel preparation procedure.
The study consists of a screening - enrollment phase, a possible preparation phase followed
      by the PillCam Endoscopy or Patency procedure visit and a post procedure telephone, follow up
      visit.

      Subjects may be assigned to any of the sub-assays done within this study as long as they
      fulfill all the inclusion and exclusion criteria and depends on their availability and their
      willingness to participate in a specific sub-assay.

      Each subject may participate in up to 15 sub-assays during his/her participation in the
      study, each ingestion will be separated in between by at least two weeks interval. A
      following capsule may be ingested only upon verification of previous capsule excretion.
      Subjects can participate in a specific sub-assay only once.

      In general, under the study protocol, per a single procedure, each subject will undergo a
      possible preparation phase followed by the PillCam endoscopy or Patency procedure and
      telephone follow up visit. Overall the expected duration for subject's participation in the
      study is expected to be up to 10 years, until subject will complete participation in up to 15
      sub-assays.

      Subject may withdraw consent at any time and will be considered as completed once completed
      at least one capsule ingestion (PillCam or Patency) or completed one of the possible
      procedures which are not involving capsule ingestion during the study period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: All device related Adverse events will be collected and reported in order to assess the device safety.
time frame: Up to 10 years
description: All device related Adverse events will be reported by number, type, seriousness, severity and duration. All device related adverse events will be captured, regardless of severity.
measure: Assessment of raw data generation in the data recorder by confirming presence of the procedure raw data output files (technical outcome)
time frame: Up to 10 years
description: A PillCam procedure will be assessed for raw data generation in the data recorder (similar to standard of care procedure), by confirming presence of the procedure output files (technical outcome). A nominal scale of Yes/No will be used to determine whether the raw data has been generated by the data recorder or not.
arm group label: PillCam™ Endoscopy System
arm group type: Experimental
description: PillCam™ Endoscopy System consists of the following subunits:
PillCam™ Capsule products' family:
PillCam™ COLON 2
PillCam™ UGI (upper gastrointestinal)
PillCam™ SB3 (small bowel 3)
PillCam™ Crohn's capsule
Patency capsule: PillCam™ Patency capsule
All the bellow system subunits are part of the Pillcam™ systems:
PillCam™ Recorder
PillCam™ Sensor Arrays & Sensor Belt
PillCam™ Software v. 9
Workstation unit
intervention type: Device
intervention name: PillCam™ Endoscopy System
description: Subject may be assigned to any procedure involving modification of any of the PillCam™ Endoscopy System component as listed in the arm description.
arm group label: PillCam™ Endoscopy System
intervention type: Drug
intervention name: Bowel prep combination
description: Subject may be assigned to any bowel preparation combination.
arm group label: PillCam™ Endoscopy System
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wisam Sbeit, M.D
role: Principal Investigator
affiliation: Galil MC, Nahariya
last name: Luba Klein
phone: +972-54-2580211
email: luba.klein@medtronic.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
sharing ipd: No