User's Manual

Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 17
Accuracy of the Device—COLON 2
Clinical Validation Study and Interpretation of Results
Evaluation of Capsule Endoscopy with PillCam COLON 2 in
Visualization of the Colon (MA-204)
Study Design
A prospective, multi-center study (MA-204) was conducted to evaluate the clinical effectiveness of the
PillCam COLON 2 (colon capsule endoscopy or CCE) device. The primary objective of the study was
to compare CCE with optical colonoscopy (OC) for agreement on absence or presence of colon polyps
(≥6 mm or ≥10 mm). There were a total of 17 enrollment sites; 11 were located in the US and 6 were
located in Israel.
Study Design and Accountability
CCE was performed on subjects 6 weeks prior to their OC procedure in order for a central reader to
interpret the CCE results prior to OC. In the initial phase of the study, colonoscopists were blinded to
CCE results when evaluating their OC findings. The data analysis for this phase of the study is reported
here.
A total of 884subjects were enrolled using the following inclusion criteria:
• Subject is between the ages of 50 and 75 years
• Subject is classified as average risk per the American Gastroenterological Association (AGA)
Guidelines on colorectal cancer (CRC) Screening (individuals without a personal or family history
of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes).
1
Among the 884 subjects enrolled, 184 subjects were excluded from the effectiveness analysis. A total of
104 subjects (11.8%) were excluded due to issues related to the performance of the CCE including 77
(8.7%) that were excluded on the basis of an inadequate colon preparation prior to CCE or a rapid
transit of the capsule through the colon. A total of 63 subjects withdrew from the study. Two subjects
were excluded because of OC procedure violations. One site was terminated due to major protocol
violations, accounting for 15 excluded subjects. The samples included in the study were average risk
asymptomatic, first time screening patients undergoing colonoscopy. The use of CCE has not been
evaluated in other populations.
A total of 700 subjects successfully completed an investigation with both CCE and OC and were
included in the effectiveness analysis. The data analysis of the effectiveness of CCE was undertaken on
a per subject basis. The comparison of CCE with OC was based on the presence or absence of at least
one finding of a polyp of size in diameter (≥6 mm or ≥10 mm) identified on OC.
PillCam COLON 2 bowel preparation:
PillCam COLON 2 bowel preparation included administration of 4 Senna tablets, a clear liquid diet and
administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution
divided into two doses: the first dose on the evening before the exam (2 liters) and the second dose on
the morning of the exam day (2 liters).
1.AGA Guidelines: Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Pol-
yps, 2008: A Joint Guideline From the American Cancer Society, the US Multi-Society Task Force on Colorectal
and the American College of Radiology; Gastroenterology 2008;134:1570-1595.