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

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: Completed
• Conditions: Small Intestine Cancer; Small Intestine Adenocarcinoma; Small Intestine Disease; Small Intestinal Ulcer Bleeding; Small Intestine Obstruction; Small Intestine Polyp

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 (Actual): 3712

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Birmingham Gastroenterology Associates
  • California
    • Escondido, California, United States, 92025
      • Gastroenterology & Liver Institute
    • Valencia, California, United States, 91355
      • Amicis Research Center
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Encore Borland-Groover
    • Miami, Florida, United States, 33134
      • Research Associates of South Florida
    • Miami, Florida, United States, 33136-1060
      • University of Miami Miller School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Digestive Healthcare of GA
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Capital Digestive Care
    • Columbia, Maryland, United States, 21045
      • Gastro Center of Maryland
    • Pikesville, Maryland, United States, 21209
      • Woodholme Gastroenterology Associates
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Health Care
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Digestive Health Associates
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hospital
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Digestive Health Institute
  • New York
    • Albany, New York, United States, 12206
      • Albany Gastroenterology Consultants
    • Brooklyn, New York, United States, 11218
      • Erber M.D. PC
    • Lake Success, New York, United States, 11042
      • Northwell Health - Cohen Children's Medical Center of New York
    • New York, New York, United States, 10128
      • New York Gastroenterology Associates
  • Ohio
    • Cleveland, Ohio, United States, 44106-1716
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
    • Toledo, Ohio, United States, 43623
      • The Toledo Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists Inc
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19431
      • USDH Clinical Research
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Palmetto Primary Care
  • Texas
    • Austin, Texas, United States, 78757
      • Austin Gastro

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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	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

• Sponsor: Medtronic - MITG
• Investigators: Study Director: Melanie Sojourner, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): September 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 (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Intestinal Diseases; Intestinal Obstruction
• 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