Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA) (SODA)

March 20, 2024 updated by: Medtronic - MITG

PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Birmingham Gastroenterology Associates
        • Contact:
        • Principal Investigator:
          • Charles Bluhm, MD
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Gastroenterology & Liver Institute
        • Principal Investigator:
          • Naveen Gara
        • Contact:
      • Valencia, California, United States, 91355
        • Recruiting
        • Amicis Research Center
        • Principal Investigator:
          • Robert Moghimi
        • Contact:
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Recruiting
        • Medical Research Center of Connecticut
        • Contact:
        • Principal Investigator:
          • David Hass
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Encore Borland-Groover
        • Principal Investigator:
          • Mark Fleisher, MD
        • Contact:
      • Miami, Florida, United States, 33134
        • Recruiting
        • Research Associates of South Florida
        • Principal Investigator:
          • Alexander Veloso, MD
        • Contact:
      • Miami, Florida, United States, 33136-1060
        • Recruiting
        • University of Miami Miller School of Medicine
        • Principal Investigator:
          • Jodie Barkin
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Completed
        • The University of Kansas Medical Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
      • Columbia, Maryland, United States, 21045
      • Pikesville, Maryland, United States, 21209
        • Recruiting
        • Woodholme Gastroenterology Associates
        • Contact:
        • Principal Investigator:
          • Todd Heller, MD
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Health Care
        • Principal Investigator:
          • David Cave, M.D
        • Contact:
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
    • Missouri
      • Chesterfield, Missouri, United States, 63005
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • The Children's Mercy Hospital
        • Sub-Investigator:
          • Jennifer Colombo, MD
        • Contact:
        • Principal Investigator:
          • Thomas Attard, MD
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • Albany Gastroenterology Consultants
        • Contact:
        • Principal Investigator:
          • Jennifer Northrop
      • Brooklyn, New York, United States, 11218
        • Recruiting
        • Erber M.D. PC
        • Principal Investigator:
          • Jonathan Erber, MD
        • Contact:
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health - Cohen Children's Medical Center of New York
        • Principal Investigator:
          • Samuel Bitton, MD
        • Contact:
      • New York, New York, United States, 10128
        • Recruiting
        • New York Gastroenterology Associates
        • Contact:
        • Principal Investigator:
          • Steven Naymagon
    • Ohio
      • Cleveland, Ohio, United States, 44106-1716
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Gerard Isenberg
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Principal Investigator:
          • Madalina Butnariu, MD
        • Contact:
      • Toledo, Ohio, United States, 43623
        • Completed
        • The Toledo Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Digestive Disease Specialists Inc
        • Contact:
        • Principal Investigator:
          • Kenneth Seres, M.D
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19431
      • Philadelphia, Pennsylvania, United States, 19107
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Principal Investigator:
          • Rich Harlan
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Palmetto Primary Care
        • Contact:
        • Principal Investigator:
          • Brett Van Leer Greenberg
    • Texas
      • Austin, Texas, United States, 78757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent Standard of Care SB3 procedure

Description

Inclusion Criteria:

  • All SB3 cases collected during standard of care procedures.
  • The subject received an explanation and understands the nature of the study and provided oral consenting

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
PillCam SB3 procedure
Subjects with normal/abnormal PillCam SB3 procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prospective collection of PillCam SB3 videos
Time Frame: Up to 7 years from study approval
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
Up to 7 years from study approval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2018

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

December 7, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT18014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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