Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
NCT ID: NCT03771508
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3712 participants
OBSERVATIONAL
2018-12-13
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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PillCam SB3 procedure
Subjects with normal/abnormal PillCam SB3 procedure
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The subject received an explanation and understands the nature of the study and provided oral consenting
Exclusion Criteria
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Melanie Sojourner
Role: STUDY_DIRECTOR
Medtronic
Locations
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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
Gastro Center of Maryland
Columbia, Maryland, United States
Woodholme Gastroenterology Associates
Pikesville, Maryland, United States
UMass Memorial Health Care
Worcester, Massachusetts, United States
Digestive Health Associates
Farmington Hills, Michigan, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Atlantic Digestive Health Institute
Morristown, New Jersey, United States
Albany Gastroenterology Consultants
Albany, New York, United States
Erber M.D. PC
Brooklyn, New York, United States
Northwell Health - Cohen Children's Medical Center of New York
Lake Success, New York, United States
New York Gastroenterology Associates
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The Toledo Clinic
Toledo, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
USDH Clinical Research
Exton, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Palmetto Primary Care
Summerville, South Carolina, United States
Austin Gastro
Austin, Texas, United States
Countries
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Other Identifiers
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MDT18014
Identifier Type: -
Identifier Source: org_study_id
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