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

Active, not recruiting

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

• Registration Number: NCT03771508
• Lead Sponsor: Medtronic - MITG

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 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 Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-11
• Study Start: 2018-12-13
• Primary Completion: 2025-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-09-29
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prospective collection of PillCam SB3 videos	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

Trial Locations

Locations (30)

Birmingham Gastroenterology Associates; 🇺🇸 Birmingham, Alabama, United States

Gastroenterology & Liver Institute; 🇺🇸 Escondido, California, United States

Amicis Research Center; 🇺🇸 Valencia, California, United States

Medical Research Center of Connecticut; 🇺🇸 Hamden, Connecticut, United States

Encore Borland-Groover; 🇺🇸 Jacksonville, Florida, United States

Research Associates of South Florida; 🇺🇸 Miami, Florida, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Digestive Healthcare of GA; 🇺🇸 Atlanta, Georgia, United States

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Capital Digestive Care; 🇺🇸 Chevy Chase, Maryland, United States

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