Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
NCT ID: NCT07089615
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2025-06-26
2026-01-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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A new capsule design is being used from that of the first phase of the study.
Capsule swallow
Participant will swallow the investigational device
Interventions
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Capsule swallow
Participant will swallow the investigational device
Eligibility Criteria
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Inclusion Criteria
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
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
45 Years
75 Years
ALL
No
Sponsors
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Capso Vision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Suejin Kim Study PI, M.D.
Role: PRINCIPAL_INVESTIGATOR
Locations
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SB Gastro Clinical Research
Chula Vista, California, United States
Gastro Care Institute
Lancaster, California, United States
Knowledge Research Center
Orange, California, United States
Advanced Research Institute
St. Petersburg, Florida, United States
Digestive Health Services
Downers Grove, Illinois, United States
Gastroenterology and Internal Medicine Specialists
Lake Barrington, Illinois, United States
Northshore Center for Gastroenterology
Libertyville, Illinois, United States
Suburban Gastroenterology
Naperville, Illinois, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Gastroenterology Group of Rochester
Rochester, New York, United States
Great Lakes Gastroenterology Research
Mentor, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLN-CVI-5794 2nd Generation
Identifier Type: -
Identifier Source: org_study_id
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