Evaluation the Efficacy of Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.

This is a multicenter, prospective, randomized study to evaluate the efficacy of CCE versus
CTC in the identification of colonic polyps in a screening population.

Subjects will be enrolled at up to 20 clinical sites in the United States. Subjects who meet
the eligibility criteria will be screened by the gastroenterology site for study
participation at a baseline visit which will also include a blood test for renal function
(eGFR), and will be evaluated on the randomized procedure day (CCE versus CTC) and again on
the day of both the blinded and unblinded OC procedures. Telephone follow-ups will be
conducted 5 - 9 days after the CCE/CTC procedure and 5 - 9 days after the unblinded OC
procedure to assess subject well-being and capture any AEs, regardless of relationship to the
CCE, CTC, or OC procedures.

All CCE RAPID® videos and CTC images will be evaluated by local and central readers. All
study analyses will be based on central reader results for both CCE and CTC. Two sets of
central readers will be utilized, one set for reading of the CCE RAPID® videos and one set
for reading the CTC studies. Both groups of readers will be experts in the reading process
for their respective procedures. Readers will provide a report of their findings to the
sponsor within 2 weeks of capsule ingestion or CTC procedure in order to allow subjects to
return within 5 weeks capsule ingestion or CTC procedure to undergo confirmatory OC. The
first OC procedure will be performed with the clinician blinded to the CCE or CTC results.
Immediately following this blinded procedure, the clinician will review the CCE or CTC
results report provided by the sponsor from the central readers, and a second unblinded OC
procedure will be performed if there are discrepancies between the CCE/CTC findings and OC.

Colonoscopy must not be performed by the same person who conducts the local CCE reading, or
anyone who has reviewed CCE/CTC results for that subject.

Bowel preparation regimens for all three procedure types will be standardized across sites.

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 colorectal cancer or adenoma (including those identified by
computed tomography [CT], optical colonoscopy, sigmoidoscopy, etc.).

2. Subject with history of negative colonoscopy within 10 years, as these subjects would
be defined as not requiring screening in this timeframe. For subjects with alternative
screening methods, refer to applicable guidelines.

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

5. Subject with current dysphagia or any swallowing disorder.

6. Subject with current serious medical conditions that would increase the risk
associated with CCE, CTC, 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 a diagnosis of gastroparesis or small bowel or large bowel dysmotility.

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 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.