Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

The first phase of the study investigated the first generation of the capsule. The second generation capsule will be investigated in the final phase of enrollment.

Inclusion criteria

• At least 45-75 years of age
• Committed to undergo a colonoscopy, independent of this study
• Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor

Exclusion criteria

• Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
• Has contraindication for capsule endoscopy or colonoscopy
• Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
• Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
• History of incomplete colonoscopy
• Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within the past 3 months and/or with history of constipation or gastroparesis.)
• Impaired cardiac function assessed as greater than NYHA Class II
• History of small- or large-bowel obstructive condition
• Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
• Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the subject at greater risk for capsule endoscope retention
• Known allergy to ingredients used in bowel preparation and boosters
• Daily and/or regular narcotic use
• Decompensated cirrhosis
• Prior abdominal radiation therapy
• Diagnosis of anorexia or bulimia
• History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study participation
• Known or suspected megacolon
• Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
• Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
• Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. WOCBP must have a negative urine pregnancy test at screening.
• Unable to follow or tolerate fasting, bowel preparation, and other study procedures
• Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study or would affect the validity of the study results
• Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
• Chronic constipation as defined by <3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements