User's Manual

PillCam Capsule Endoscopy
18 Accuracy of the Device—COLON 2
Following capsule ingestion and depending on capsule progression through the digestive tract, subjects
were required to take a boost of an additional volume of laxative (SuPrep) in order to enhance capsule
propulsion and maintain adequate cleansing of the colon. Per procedure progress, in case the capsule
remained in the stomach more than an hour after ingestion a prokinetic medication may have been
administered. Upon SB detection, a first boost of 6 ounces diluted to 16 ounces was administered. Unless
the PillCam capsule was excreted, a second boost of 3 ounces diluted to 8 ounces may have been
administered 3 hours after the first boost. If towards the end of the procedure (2 hours after the second
boost) the capsule was not excreted, the subject was asked to take a 10mg Bisacodyl suppository according
to package insert instructions. Subjects were allowed to eat 2 hours after suppository intake or after capsule
excretion.
Subjects were encouraged to drink clear liquids such as water, isotonic drinks, tea or other pulp-free juices
throughout their preparation and examination.
Descriptive Analysis Sizes of the largest colon polyp identified in a subject by OC and CCE, regardless of
segmental location, were compared (Table 1). In particular, on OC 219 subjects were identified as having a
colon polyp that measured 5 mm or less in diameter, 115 subjects were identified as having a colon polyp
equal to or greater than 6 mm in diameter, but less than 10 mm in diameter, and 77 subjects were identified
as having a colon polyp measuring at least 10 mm in diameter. The overall prevalence of subjects with any
polyp found on OC was 58.7% (411/700). The prevalence of subjects found to have at least one polyp at
least 6 mm in diameter was 27.4% (192/700), and the prevalence of subjects found to have at least one
polyp at least 10 mm in size was 11.0% (77/700).
Among 115 subjects with a polyp identified on OC that was greater than 6 mm but less than 10 mm in
diameter, CCE also identified 55 (47.8%) subjects with a polyp greater than 6 mm but less than 10 mm in
diameter anywhere in the colon, and 19 (16.5%) subjects with a 10 mm in diameter sized polyp, for a total
of 74 subjects (64.3%) with a CCE detected polyp of 6 mm or greater.
Among 77 subjects with a polyp identified on OC that was greater than 10 mm in diameter, CCE identified
a polyp anywhere in the colon less than 6 mm in diameter in 12 (15.6%) subjects, a polyp greater than 6 mm
but less than 10 mm in diameter in 18 (23.4%) subjects, and a polyp measuring at least 10 mm in diameter
in 37 (48.1%) subjects. Thus, CCE identified a total of 55 subjects (71.4%) with a polyp of 6 mm or greater.
CCE failed to identify any polyp of 6 mm or greater in 22 (28.6%) subjects and any polyp of 10 mm or
greater in 40 (51.9%) subjects.
Table 1: Comparison of the polyp with the largest diameter (mm) identified by OC and CCE in a subject,
regardless of segmental location
Max CCE
(mm)
Max OC (mm)
0 0<OC<6 6≤OC<10 10≤OC Total
0 168 84 20 10 282
0<CCE<6 90 71 21 12 194
6≤CCE<10 18 52 55 18 143
10≤CCE 13 12 19 37 81
Total 289 219 115 77 700