User's Manual

Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 25
Published Studies
There have been two published studies utilizing PillCam COLON 2 which are summarized below. The
statistical analysis performed on the two published studies below is different from the FDA clinical
study presented above (Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of
the Colon (MA-204)).
Prospective multicenter performance evaluation of the second-generation colon capsule
compared with colonoscopy
1
This trial was conducted in Israel by Eliakim et al to evaluate the ability of the PillCam COLON 2
capsule endoscopy system to detect polyps and other pathologies in the colon. A total of 104 patients
were enrolled using the following inclusion criteria:
1. Subject is between the ages of 18 and 57 years
2. Subject is able and agrees to sign the Informed Consent Form
• Subject was referred to colonoscopy for at least one of the following reasons:
• Colorectal cancer screening
• Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive fecal occult blood
test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset
• Positive findings in the colon on a GI radiographic study
• Personal history of colorectal cancer (CRC) or adenomatous polyps and at least 5 years since
last conventional colonoscopy
Patients were excluded from the study for the standard contraindications for small bowel capsule
endoscopy such as:
1. Dysphagia,
2. Life threatening conditions,
3. Use of a pacemaker,
4. Current pregnancy,
5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs), or
6. Contraindications to bowel preparation and prokinetic agents used in the study.
98 patients were included in the accuracy analysis with 66% males and 34% females at an average age
of 49.8 years (18-57). For the detection of patients with polyps ≥6 mm, a true positive result was
considered when at least one polyp equal to or larger than 4 mm was identified by PillCam COLON 2
and at least one polyp equal to or larger than 6 mm was identified by colonoscopy. For the detection of
patients with polyps ≥ 10 mm, a true positive result was considered when at least one polyp equal to or
larger than 7 mm was identified by PillCam COLON 2 and at least one polyp equal to or larger than
10 mm was identified by colonoscopy.
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.