Spots Global Cancer Trial Database for Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
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Trial Identification
Brief Title: Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
Official Title: PillCam SB3 Registry for Development and Validation of Improved Algorithms for GI Pathologies Detection
Study ID: NCT03771508
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
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