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
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 Type
OBSERVATIONAL
Enrollment
3,712
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
Time frame: Up to 7 years from study approval
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 20 more locations