Colonic Polyps
Conditions
Brief summary
Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied. The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps and to show that AI-based CADe improves the polyp-detection accuracy and efficiency of capsule video readers. It will use colonoscopy results as a reference. The participant will: 1. prep for and swallow a study capsule and then 2. prep for and undergo a colonoscopy either the following day or 3-6 weeks later
Interventions
DEVICECapsule swallow
Participant will swallow the investigational device
Sponsors
Capso Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 45-75 years of age 2. Committed to undergo a colonoscopy. 3. 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
1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps 2. Has contraindication for capsule endoscopy or colonoscopy 3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome 4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease 5. History of incomplete colonoscopy 6. 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). 7. Impaired cardiac function assessed as greater than NYHA Class II 8. History of small- or large-bowel obstructive condition 9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis 10. 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 11. Known allergy to ingredients used in bowel preparation and boosters 12. Daily and/or regular narcotic use 13. Decompensated cirrhosis 14. Prior abdominal radiation therapy 15. Diagnosis of anorexia or bulimia 16. 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 17. Known or suspected megacolon 18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule 19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis 20. 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. 21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures 22. 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 23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study 24. 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 |
|---|---|---|
| Positive Percentage Agreement | From capsule swallow to Colonoscopy - up to 6 weeks | • Positive Percent Agreement (PPA) of the study device with computer assisted detection (CADe) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is ≥ 6 mm, where a match is considered to have occurred if a polyp detected by the device is assessed as having a size within plus or minus 50% of the size of the polyp detected by OC and as having a location within the same or an adjacent colon segment. |
| Negative Percentage Agreement | From Capsule swallow to colonoscopy - Up to 6 weeks | • Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm. |
Countries
United States
Contacts
CONTACTTaylor Williamsen Principle CRA/Study Lead
CONTACTRebecca Petersen Sr. Director of Clinical Affairs
PRINCIPAL_INVESTIGATORSuejin Kim Study PI, M.D.
Outcome results
None listed