Status:
COMPLETED
Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
Lead Sponsor:
Medtronic - MITG
Conditions:
Small Intestine Disease
Small Intestine Cancer
Eligibility:
All Genders
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
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...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
December 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
3712 Patients enrolled
Trial Details
Trial ID
NCT03771508
Start Date
December 13 2018
End Date
September 30 2025
Last Update
October 27 2025
Active Locations (30)
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1
Birmingham Gastroenterology Associates
Birmingham, Alabama, United States, 35209
2
Gastroenterology & Liver Institute
Escondido, California, United States, 92025
3
Amicis Research Center
Valencia, California, United States, 91355
4
Medical Research Center of Connecticut
Hamden, Connecticut, United States, 06518