User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 14 of 90
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4.6 Benefit and Risks of the C-Scan® procedure
Benefits:
 C-Scan
®
system is subject-friendly tool for structural analysis of the colon.
 C-Scan
®
system provides an alternative for those subjects who refuse or cannot
undergo colonoscopy procedure.
 No cleansing of the intestine is required prior the use of the C-Scan
®
system.
 The procedure does not require sedation, intubation or bowel insufflation.
 Subjects may continue with their normal daily routine during the procedure.
 C-Scan
®
system offers a simple, safe and non-invasive alternative to traditional
imaging procedures.
Risks:
 Exposure to radiation. The C-Scan
®
Cap includes radiation source and in rare cases
a local radiation exposure may occur.
 Abdominal X-ray may be required in order to verify the C-Scan
®
Cap excretion in
cases that the C-Scan
®
Cap in the GI system for more than 2 weeks.
 C-Scan
®
Cap retention of more than 2 weeks may require intervention in order to
extract the C-Scan
®
Cap.
 Rare risk of choking during the C-Scan
®
Cap ingestion .
 Obstruction, perforation, and mucosal injury or bleeding.
 Allergic reaction to Iodine contrast medium.