Optimization of the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects
undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1
to receive one of two bowel preparation regimens prior to PillCam CCE.

Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the
eligibility criteria will be screened for study participation at a baseline visit and will
be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be
conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient
well-being, and capture any AEs.

Inclusion Criteria:

1. Subject is between 50 and 75 years of age.

2. Subject is classified as average risk per the American Gastroenterological
Association Guidelines on Colorectal Cancer Screening: Individuals without a personal
or family history of CRC or adenomas, inflammatory bowel disease, or high-risk
genetic syndromes.

3. Subject is willing and able to participate in the study procedures and to understand
and sign the informed consent.

Exclusion Criteria:

1. Subject with history of polyps (including those identified by computed tomography
[CT], optical colonoscopy, sigmoidoscopy, etc.).

2. Subject with history of negative colon assessment (including CT, optical colonoscopy,
sigmoidoscopy etc.) within 5 years as these subjects would be defined not requiring
screening in this time frame.

3. Subject with suspected or diagnosed with hematochezia, melena, iron deficiency with
or without anemia, or any other rectal bleeding, including positive fecal occult
blood test of any variety.

4. Subject with any condition believed to have an increased risk of capsule retention
such as suspected or known bowel obstruction, stricture, or fistula.

5. Subject with dysphagia or any swallowing disorder.

6. Subject with serious medical conditions that would increase the risk associated with
capsule or colonoscopy that are so severe that screening would have no benefit.

7. Subject with a cardiac pacemaker or other implanted electromedical device.

8. Subject expected to undergo MRI examination within 7 days after ingestion of the
capsule.

9. Subject with clinical evidence of renal disease, including clinically significant
laboratory abnormalities of renal function within the past 6 months, or at any time
in the past if not tested within the last 6 months, defined as creatinine, blood urea
nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local
laboratory reference range.

10. Subject with known gastrointestinal motility disorders.

11. Subject with allergies or known contraindication to the medications or preparation
agents used in the procedure as described in the relevant instructions for use.

12. Subject with comorbidities which, in the opinion of the investigator, will not be
appropriate for the study or the subject has an estimated life expectancy of less
than 6 months.

13. Subject is considered to be part of a vulnerable population (e.g. prisoners or those
without sufficient mental capacity).

14. Subject is pregnant, suspected pregnant, or is actively breast-feeding. Females of
child-bearing potential will be required to provide either a urine pregnancy test or
serum pregnancy test as part of the participant's standard of care regardless of
their participation in the study (except for subjects who are surgically sterile or
are post-menopausal for at least two years).

15. Subject has participated in an investigational drug or device research study within
30 days of enrollment that may interfere with the subject's safety or ability to
participate in this study.