Collecting images for AI software development in colonoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to gather capsule images to aid in the development of computer-aided detection (CADe) software for the CapsoCam® Colon (CV-3E). Healthy volunteers aged 45-75 who are referred for colonoscopy will ingest the capsule after adhering to specific bowel preparation and dietary guidelines. Participants will retrieve the capsule after it passes through their system and return it to the sponsor, with no analysis performed during this protocol. Follow-up will include a phone call to ensure compliance and gather any additional information.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 45-75 years of age
2. Choose to participate and must have signed the IRB-approved informed consent document.

Exclusion Criteria:

1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
2. Colonoscopy within the past 4 years that demonstrated polyps that were removed.
3. Has contraindication for capsule endoscopy
4. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
5. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
6. History of incomplete colonoscopy
7. 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).
8. Impaired cardiac function assessed as greater than NYHA Class II
9. History of small- or large-bowel obstructive condition
10. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
11. 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
12. Known allergy to ingredients used in bowel preparation and boosters
13. Daily and/or regular narcotic use
14. Decompensated cirrhosis
15. Prior abdominal radiation therapy
16. Diagnosis of anorexia or bulimia
17. 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
18. Known or suspected megacolon
19. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
20. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
21. Pregnant or nursing or of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening.
22. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
23. 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
24. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
25. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements

Where it's running

• Advanced Research Institute Inc
  New Port Richey, Florida, United States Recruiting
• Advanced Gastroenterology Associates, LLC
  Palm Harbor, Florida, United States Recruiting
• Digestive Diseases Center of Hattiesburg, LLC
  Hattiesburg, Mississippi, United States Recruiting
• Gastroenterology Consultants of Southwest Virginia
  Roanoke, Virginia, United States Recruiting

Study contacts

• Study coordinator: Keri Jorgenson, MBA
• Email: keri.jorgenson@capsovision.com
• Phone: 847-400-4631

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.