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

Up to 5000 PillCam SB3 videos (including PillCam reports) and raw data files with abnormal
findings will be collected in up to 25 medical centers in the US. Study duration is up to 3
years from IRB approval.

Medical center study sites will provide relevant videos (including PillCam reports) and raw
data from patients who underwent a SB3 procedure and had abnormal findings on their PillCam
report. 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 it to the sponsor. Videos, reports and raw data files will be
de-identified in a manner that is unretractable by the sponsor clinical study team members.

Inclusion Criteria:

- Any SB3 procedure with abnormal finding detected. The list of pathologies that will be
collected includes but is not limited to:Fresh Blood, Oxygenated blood (Melena/black
blood/digested blood), Polyp, tumor, Mass, Stricture, Blood clots,Angioectasia,
Erythema, Mosaic pattern, VilliAtrophy, Scalloping, Melanoma, Polyposis, Varices,
Mucosal edema, Submucosal lesions.

Exclusion Criteria:

- Any normal or inconclusive SB3 procedure will not be collected