<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/NCT03771508</url>
  </required_header>
  <id_info>
    <org_study_id>MDT18014</org_study_id>
    <nct_id>NCT03771508</nct_id>
  </id_info>
  <brief_title>Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)</brief_title>
  <acronym>SODA</acronym>
  <official_title>PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational, Multicenter, Post-market, Minimal risk, Prospective data collection of PillCam&#xD;
      SB3 videos (including PillCam reports) and raw data files and optional collection of&#xD;
      Eneteroscopy reports&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 8000 PillCam SB3 videos (including PillCam reports) and raw data files will be&#xD;
      collected in up to 50 medical centers in the US. Study duration is up to 7 years from IRB&#xD;
      approval.&#xD;
&#xD;
      Medical center study sites will provide relevant videos (including PillCam reports) and raw&#xD;
      data from patients who underwent SB3 procedures.&#xD;
&#xD;
      Per patient demographic data will be also collected to provide a description of the study&#xD;
      population characteristics and disposition.&#xD;
&#xD;
      Additional Standard of care data collection might be performed (optional). This data will&#xD;
      include a de-identified Eneteroscopy report, from patients enrolled to the study and referred&#xD;
      to Eneteroscopy procedure (all types of Eneteroscopies), following findings identified during&#xD;
      the PillCamTM SB procedure, as part of the standard of care procedure. This data might be&#xD;
      collected retrospectively for enrolled patients who underwent an Eneteroscopy procedure. The&#xD;
      de-identified reports will be used by MDT GI research and development team to further develop&#xD;
      and validated SB capsule localization.&#xD;
&#xD;
      Study subjects will not undergo any additional procedures, nor will their diagnosis and&#xD;
      subsequent treatment pathway be changed for the purpose of the registry.&#xD;
&#xD;
      The data will be used by MDT GIs research and development team for the development and&#xD;
      validation of improved and new detectors in the PillCam software.&#xD;
&#xD;
      The videos (including PillCam reports) and raw data files will be de-identified at the&#xD;
      medical center by representatives who are authorized and delegated to review medical records,&#xD;
      prior to providing them to the sponsor. All data in the study- videos, reports, raw data&#xD;
      files and demographic information will be de-identified in a manner that is untraceable by&#xD;
      the sponsor clinical study team members.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prospective collection of PillCam SB3 videos</measure>
    <time_frame>Up to 7 years from study approval</time_frame>
    <description>sponsor database will be expanded with images of pathologies and normal mucosa for future development and validation of improved algorithms for GI pathologies detection with the PillCam platform</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Small Intestine Disease</condition>
  <condition>Small Intestine Cancer</condition>
  <condition>Small Intestinal Ulcer Bleeding</condition>
  <condition>Small Intestine Obstruction</condition>
  <condition>Small Intestine Adenocarcinoma</condition>
  <condition>Small Intestine Polyp</condition>
  <arm_group>
    <arm_group_label>PillCam SB3 procedure</arm_group_label>
    <description>Subjects with normal/abnormal PillCam SB3 procedure</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent Standard of Care SB3 procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All SB3 cases collected during standard of care procedures.&#xD;
&#xD;
          -  The subject received an explanation and understands the nature of the study and&#xD;
             provided oral consenting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Roslana Fox</last_name>
    <phone>972-542355303</phone>
    <email>roslana.fox@medtronic.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zina Goldbaum</last_name>
    <email>zina.goldbaum@medtronic.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Birmingham Gastroenterology Associates</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patty Fields</last_name>
      <phone>205-271-8000</phone>
      <email>PFields@bgapc.com</email>
    </contact>
    <investigator>
      <last_name>Charles Bluhm, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gastroenterology &amp; Liver Institute</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Dejesus</last_name>
      <email>ldejesus@giandliver.org</email>
    </contact>
    <investigator>
      <last_name>Naveen Gara</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Amicis Research Center</name>
      <address>
        <city>Valencia</city>
        <state>California</state>
        <zip>91355</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Moghimi, Dr</last_name>
      <phone>818-924-4708</phone>
    </contact>
    <investigator>
      <last_name>Robert Moghimi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical Research Center of Connecticut</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Nikolich</last_name>
      <email>jnikolich@gastrocenter.org</email>
    </contact>
    <investigator>
      <last_name>David Hass</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Encore Borland-Groover</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cynthia Buda</last_name>
      <phone>904-680-0871</phone>
    </contact>
    <investigator>
      <last_name>Mark Fleisher, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Research Associates of South Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Valero</last_name>
      <phone>786-476-8790</phone>
      <email>mvalero@research-associates.org</email>
    </contact>
    <investigator>
      <last_name>Alexander Veloso, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136-1060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Niurka Colina</last_name>
      <email>nxc610@miami.edu</email>
    </contact>
    <investigator>
      <last_name>Jodie Barkin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Digestive Healthcare of GA</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Debeeh Legaspi</last_name>
      <email>dlegaspi@digestivehealthcare.net</email>
    </contact>
    <investigator>
      <last_name>Michael Galambox</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Capital Digestive Care</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ipninder Singh</last_name>
      <email>ipninder.singh@capitaldigestivecare.com</email>
    </contact>
    <investigator>
      <last_name>Ali Amir</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gastro Center of Maryland</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Candace Parks</last_name>
      <phone>410-290-6677</phone>
      <email>cparks@gastromaryland.com</email>
    </contact>
    <contact_backup>
      <last_name>Jessica Stotler</last_name>
      <phone>410-290-6677</phone>
      <email>jstotler@gastromaryland.com</email>
    </contact_backup>
    <investigator>
      <last_name>Rudrajit Rai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Woodholme Gastroenterology Associates</name>
      <address>
        <city>Pikesville</city>
        <state>Maryland</state>
        <zip>21209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristina Agel</last_name>
      <email>kagel@woodholmegi.com</email>
    </contact>
    <investigator>
      <last_name>Todd Heller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Health Care</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Foley</last_name>
      <phone>774-442-4098</phone>
      <email>Anne.Foley@umassmemorial.org</email>
    </contact>
    <investigator>
      <last_name>David Cave, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Digestive Health Associates</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Lezovich</last_name>
      <email>LauraL@digesthealth.com</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Gamble</last_name>
      <email>jenniferg@digesthealth.com</email>
    </contact_backup>
    <investigator>
      <last_name>Phillip Goldmeier</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Research Professionals</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63005</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianne Tow</last_name>
      <email>mtow@clinicalresearchprofessionals.net</email>
    </contact>
    <investigator>
      <last_name>Steve Fern, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Atlantic Digestive Health Institute</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Rondon</last_name>
      <email>Nicole.Rondon@atlantichealth.org</email>
    </contact>
    <investigator>
      <last_name>Razvan Arsenescu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Albany Gastroenterology Consultants</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Alexander</last_name>
      <email>malexander@albanygi.com</email>
    </contact>
    <investigator>
      <last_name>Jennifer Northrop</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Erber M.D. PC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Erber, MD</last_name>
      <email>drjonerber@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jonathan Erber, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwell Health - Cohen Children's Medical Center of New York</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sujay Joseph</last_name>
      <email>sjoseph37@northwell.edu</email>
    </contact>
    <investigator>
      <last_name>Samuel Bitton, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Gastroenterology Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salitah Qureshi</last_name>
      <phone>347-248-8719</phone>
      <email>salitah.qureshi@nyga.md</email>
    </contact>
    <investigator>
      <last_name>Steven Naymagon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106-1716</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wendy Brock</last_name>
      <email>wendy.brock@uhhospitals.org</email>
    </contact>
    <investigator>
      <last_name>Gerard Isenberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmad Abusharkh</last_name>
      <email>Ahmad.Abusharkh@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Madalina Butnariu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Toledo Clinic</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jim Brock</last_name>
      <email>JBrock@toledoclinic.com</email>
    </contact>
    <contact_backup>
      <last_name>Julianne Horstman</last_name>
      <email>jhorstman@toledoclinic.com</email>
    </contact_backup>
    <investigator>
      <last_name>Antwan Atia</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Specialists Inc</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather LoMonaco</last_name>
      <phone>405-702-1246</phone>
      <email>hlomonaco@okddsi.net</email>
    </contact>
    <investigator>
      <last_name>Kenneth Seres, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>USDH Clinical Research</name>
      <address>
        <city>Exton</city>
        <state>Pennsylvania</state>
        <zip>19431</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabel Monterrosa</last_name>
      <email>IMonterrosa@usdhealth.com</email>
    </contact>
    <investigator>
      <last_name>Nirav Shah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Matthews</last_name>
      <email>Michael.Matthews@jefferson.edu</email>
    </contact>
    <investigator>
      <last_name>David Kastenberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Palmisciano</last_name>
      <phone>401-369-4035</phone>
      <email>APalmisciano@Lifespan.org</email>
    </contact>
    <investigator>
      <last_name>Rich Harlan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Palmetto Primary Care</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dennis Paige</last_name>
      <phone>843-376-0670</phone>
      <email>PLDennis@palmettoprimarycare.com</email>
    </contact>
    <investigator>
      <last_name>Brett Van Leer Greenberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Austin Gastro</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78757</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Atkinson</last_name>
      <phone>512-420-0186</phone>
      <email>Heather.Atkinson@austingastro.com</email>
    </contact>
    <investigator>
      <last_name>Harish Gagneja</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</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>Intestinal Neoplasms</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Intestinal Obstruction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Patient data will not be shared.</ipd_description>
  </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/NCT03771508
org study id: MDT18014
nct id: NCT03771508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is us export: No
Observational, Multicenter, Post-market, Minimal risk, Prospective data collection of PillCam
      SB3 videos (including PillCam reports) and raw data files and optional collection of
      Eneteroscopy reports
Up to 8000 PillCam SB3 videos (including PillCam reports) and raw data files will be
      collected in up to 50 medical centers in the US. Study duration is up to 7 years from IRB
      approval.

      Medical center study sites will provide relevant videos (including PillCam reports) and raw
      data from patients who underwent SB3 procedures.

      Per patient demographic data will be also collected to provide a description of the study
      population characteristics and disposition.

      Additional Standard of care data collection might be performed (optional). This data will
      include a de-identified Eneteroscopy report, from patients enrolled to the study and referred
      to Eneteroscopy procedure (all types of Eneteroscopies), following findings identified during
      the PillCamTM SB procedure, as part of the standard of care procedure. This data might be
      collected retrospectively for enrolled patients who underwent an Eneteroscopy procedure. The
      de-identified reports will be used by MDT GI research and development team to further develop
      and validated SB capsule localization.

      Study subjects will not undergo any additional procedures, nor will their diagnosis and
      subsequent treatment pathway be changed for the purpose of the registry.

      The data will be used by MDT GIs research and development team for the development and
      validation of improved and new detectors in the PillCam software.

      The videos (including PillCam reports) and raw data files will be de-identified at the
      medical center by representatives who are authorized and delegated to review medical records,
      prior to providing them to the sponsor. All data in the study- videos, reports, raw data
      files and demographic information will be de-identified in a manner that is untraceable by
      the sponsor clinical study team members.
observational model: Case-Only
time perspective: Prospective
measure: Prospective collection of PillCam SB3 videos
time frame: Up to 7 years from study approval
description: sponsor database will be expanded with images of pathologies and normal mucosa for future development and validation of improved algorithms for GI pathologies detection with the PillCam platform
arm group label: PillCam SB3 procedure
description: Subjects with normal/abnormal PillCam SB3 procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Roslana Fox
phone: 972-542355303
email: roslana.fox@medtronic.com
last name: Zina Goldbaum
email: zina.goldbaum@medtronic.com
facility: 
status: Recruiting
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country: United States
responsible party type: Sponsor
mesh term: Intestinal Neoplasms
mesh term: Intestinal Diseases
mesh term: Intestinal Obstruction
sharing ipd: No
ipd description: Patient data will not be shared.