Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps

Exclusion Criteria

• •1. Subject who is not a suitable candidate for a colonoscopy
• •2. Known history of dysphagia or other swallowing disorders.
• •3. History of the following:
• •1. Colorectal polyps
• •2. A personal history of CRC
• •3. A family history of CRC or adenomatous polyps diagnosed in a relative before 60 years of age
• •4. A history of inflammatory bowel disease of significant duration
• •5. One of two (2) hereditary syndromes
• •4. Known motility disorders:
• •1. Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
• •2. Ongoing diarrhea defined as passage of loose or watery stools at least three times within 24-hour
• •3. Delayed gastric emptying.
• •5. Known IBD (Crohn's, Ulcerative Colitis)
• •6. Prior history of gastrointestinal tract surgery.
• •7. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by a physician
• •8. Any condition believed to have an increased risk for capsule retention, known strictures, known bowel adhesion or 'obstacles' to free passage of the capsule (such as esophageal diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by a physician.
• •9. Significant change in diameter and frequency of stool within the last 3 months.
• •10. GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena.
• •11. Implanted cardiac device or any other implanted active device
• •12. Known sensitivity to iodine
• •13. Acute kidney failure
• •14. Known condition which precludes compliance or is contraindicated with study and/or device instructions.
• •15. Any procedure requiring contrast agent, or which may introduce electronic interference (such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled within 14 days of C-Scan ingestion
• •16. Nuclear imaging procedure within the four (4) weeks preceding the C-Scan procedure.
• •17. Known condition of opioid use disorder and/or alcoholism.
• •18. Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization).
• •19. Concurrent participation in another clinical trail using any investigational drug or device.
• •20. Previous colonoscopy performed five (5) years or less before date of enrolment
• •21. Subjects who tend to hyperhidrosis in the back area