User's Manual

PillCam Capsule Endoscopy
26 Accuracy of the Device—COLON 2
The accuracy of the PillCam COLON 2 capsule endoscopy system for patients with polyps is listed in the
table below:
Second-generation colon capsule endoscopy compared with colonoscopy
1
This trial was conducted in eight European sites by Spada et al to assess the ability of the PillCam
COLON 2 capsule endoscopy system to detect polyps and other pathologies in the colon. A total of 117
patients were enrolled using the following inclusion criteria:
1. Subject is between the ages of 18 and 80 years
2. Subject is referred to colonoscopy for at least one of the following reasons:
• Colorectal cancer screening,
• Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change
of bowel habits for age ≤50,
• Positive findings in the colon (e.g. Polyp ≥ 10mm), or
• Personal history of significant polyps (≥ 6 mm) that were removed 3 or more years previously.
Patients were excluded from the study for the following reasons:
1. Dysphagia or any swallowing disorder,
2. Congestive heart failure,
3. Allergy or other known contraindication to the medications used in the study,
4. An increased risk for capsule retention (i.e. Crohn’s disease, previous abdominal surgeries, ongoing
nonsteroidal anti-inflammatory drug use), or
5. Cardiac pacemaker or other implanted electromedical device.
109 patients were included in the accuracy analysis with 59% males and 41% females at an average age of
58.0 years (26-79). For a given polyp to be considered a match between PillCam COLON 2 and
colonoscopy, it had to be assessed within 50% of the size of the largest estimate of the two studies and as
appearing within the same colon segment or in adjacent segments. Following the polyp-match algorithm,
for a patient to be considered to be a true-positive at least one polyp in a given size category (i.e., equal to or
larger than 6 mm or equal to or larger than 10 mm), had to be present in PillCam COLON 2 and
colonoscopy reports.
Accuracy
≥ 6 mm ≥ 10 mm
Sensitivity %
(95% CI)
89%
(70%–97%)
88%
(56%–98%)
Specificity %
(95% CI)
76%
(72%–78%)
89%
(86%–90%)
1.Spada C, Hassan C, Munoz-Navas M, et al. Second-generation colon capsule endoscopy compared with colonoscopy.
Gastrointest Endosc 2011 Sep;74(3):581-589.