Colonic Polyps
Conditions
Brief summary
The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol. Participants will * adhere to bowel prep instructions and dietary requirements * ingest pro-kinetic medication and CapsoCam® Colon (CV-3E) * adhere to booster regimen and dietary requirements until capsule passes * retrieve capsule with retrieval kit per instructions and mail back to sponsor * participate in follow-up phone call
Interventions
DEVICEColon Capsule
All participants will swallow the CapsoCam® Colon (CV-3E) for this study.
Sponsors
Capso Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect Capsule Images | 4-6 months | No assessment will be done for this protocol. Videos will be collected for AI development for use in future study. |
Countries
United States
Outcome results
None listed