Evaluation of C-Scan capsule in identifying subjects with elevated risk of colon polyps

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Colon Polyps
  • Age: Between 50 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Able to provide a signed informed consent
    2. Willing and able to comply with the specified study requirements and can be contacted by telephone
    3. Scheduled for colonoscopy procedure no later than 60 days after C-Scan ingestion
    4. Maximal abdominal circumference < 125 cm

You may not be eligible for this study if the following are true:

    1. Subject who is not a suitable candidate for colonoscopy
    2. Known history of dysphagia or other swallowing disorders
    3. History of colorectal polyps
    4. Personal history of CRC
    5. Family history of CRC or adenomatous polyps diagnosed in a relative before the age of 60 years
    6. History of inflammatory bowel disease of significant duration
    7. Presence of one of two (2) hereditary syndromes
    8. Known motility disorders:
      • Chronic constipation: less than three (3) bowel movements/week, without the use of laxatives within the last three (3) months
      • Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hours
      • Delayed gastric emptying
    9. Known IBD (Crohn's, Ulcerative Colitis)
    10. Prior history of gastrointestinal tract surgery
    11. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
    12. 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 diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by physician discretion
    13. Significant changes in diameter and frequency of stool within the last 3 months
    14. GI bleeding within the last 3 months
    15. Implanted cardiac device or any other implanted active device
    16. Known sensitivity to iodine
    17. Acute kidney failure
    18. Known condition which precludes compliance or is contraindicated with study and/or device instructions
    19. Has 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
    20. Nuclear imaging procedure during 4 weeks before C-Scan procedure
    21. Known condition of opioid use disorder and/or alcoholism



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