Collecting images for AI software development in colonoscopy
Data Collection for CapsoView AI Software Development for the CapsoCam® Colon (CV-3E)
This study is trying to collect images from a special capsule that people swallow during a colonoscopy to help develop better computer software for detecting issues in the colon.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Capso Vision, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (New Port Richey, Florida and 3 other locations) |
| Trial ID | NCT06916845 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy volunteers aged 45-75 who have been referred for a colonoscopy.
Not a fit: Patients with a history of certain gastrointestinal conditions or recent colonoscopy procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of colonoscopy procedures by improving AI software used for detecting colonic polyps.
How similar studies have performed: While this approach is focused on software development, similar studies utilizing AI in medical imaging have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Port Richey, Florida and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.