User's Manual

Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 21
Safety
Only one (0.1%) case (out of 884 cases) was reported within this study as a serious adverse event
(abdominal pain related to OC procedure). The event resolved the following day.
A total of 142 non-serious adverse events related to the study occurred in 101 (11%) out of 884 subjects.
• Three adverse events were reported as related to the capsule procedure and resolved within the
same day (i.e., severe gagging reflex and mild vomiting and abdominal cramping).
• Eleven adverse events were reported as related to the colonoscopy procedure as follows:
• 6 moderate adverse events, out of which 5 occurred in the same subject and resolved within the
same day (i.e., fever, headache, abdominal pain, bloating and nausea); a second subject suffered
from moderate abdominal pain that resolved within 3 days.
• 5 mild adverse events resolved within 8 days (i.e., abdominal pain / cramping (3 cases), fever
and bleeding-old blood).
The remaining 128 adverse events were reported as related to the colon preparation (prior to CE and
optical colonoscopy procedures).
Appendix
Definitions of categories of subject level agreement of CCE with OC used in location- and size-
based agreement analysis
Agreement Analysis, polyp size threshold 6 mm
When no OC polyp ≥ 6 mm was detected, a CCE finding of no polyp ≥ 6 mm would be a True Negative
finding. A CCE finding of a polyp ≥ 6 mm anywhere in the colon would be a False Positive finding.
When an OC polyp ≥ 6 mm was detected, a CCE polyp that was within the range of 50% smaller
diameter or any size larger in diameter, and located in the same or an adjacent colon segment would be
a True Positive finding. When an OC polyp ≥ 6 mm was detected, a CCE polyp that was below the 50%
smaller diameter in the same or an adjacent colon segment would be a False Negative finding. An
exception was made in the situation where an OC polyp ≥ 20 mm and a CCE polyp ≥ 10 mm were
identified in the same or an adjacent colon segment. This was also considered a True Positive finding.
Agreement Analysis, polyp size threshold 10 mm
The same algorithm would apply for an OC polyp ≥ 10 mm in terms of determining True Positive,
True Negative, False Positive and False Negative findings.
The use of the 50% margin of error rule for the comparison of the diameter of colon polyps as estimated
by both OC and CCE was incorporated into this study analysis in order to be consistent with the two
other published clinical trials comparing the PillCam COLON 2 device and optical colonoscopy.
1 2
1.Eliakim R, Yassin K, Niv Y, et al. Prospective multicenter performance evaluation of the second- generation colon
capsule compared with colonoscopy. Endoscopy 2009 Dec;41(12):1026-1031.
2.Spada C, Hassan C, Munoz-Navas M, et al. Second-generation colon capsule endoscopy com-pared with colonos-
copy. Gastrointest Endosc 2011 Sep;74(3):581-589.