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
1 other identifier
observational
3,712
1 country
30
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedStudy Start
First participant enrolled
December 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedOctober 27, 2025
July 1, 2025
6.6 years
December 7, 2018
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
PillCam SB3 procedure
Subjects with normal/abnormal PillCam SB3 procedure
Eligibility Criteria
Patients who underwent Standard of Care SB3 procedure
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (30)
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209, United States
Gastroenterology & Liver Institute
Escondido, California, 92025, United States
Amicis Research Center
Valencia, California, 91355, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
Encore Borland-Groover
Jacksonville, Florida, 32256, United States
Research Associates of South Florida
Miami, Florida, 33134, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136-1060, United States
Digestive Healthcare of GA
Atlanta, Georgia, 30309, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Capital Digestive Care
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Woodholme Gastroenterology Associates
Pikesville, Maryland, 21209, United States
UMass Memorial Health Care
Worcester, Massachusetts, 01655, United States
Digestive Health Associates
Farmington Hills, Michigan, 48334, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Atlantic Digestive Health Institute
Morristown, New Jersey, 07960, United States
Albany Gastroenterology Consultants
Albany, New York, 12206, United States
Erber M.D. PC
Brooklyn, New York, 11218, United States
Northwell Health - Cohen Children's Medical Center of New York
Lake Success, New York, 11042, United States
New York Gastroenterology Associates
New York, New York, 10128, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
The Toledo Clinic
Toledo, Ohio, 43623, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112, United States
USDH Clinical Research
Exton, Pennsylvania, 19431, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Palmetto Primary Care
Summerville, South Carolina, 29486, United States
Austin Gastro
Austin, Texas, 78757, United States
Study Officials
- STUDY DIRECTOR
Melanie Sojourner
Medtronic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2018
First Posted
December 11, 2018
Study Start
December 13, 2018
Primary Completion
June 30, 2025
Study Completion
September 30, 2025
Last Updated
October 27, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
Patient data will not be shared.