Evaluating a new capsule endoscope for detecting colonic polyps

Prospective Open Label, Pivotal Study of the Accuracy of The CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

This study is testing a new capsule endoscope to see if it can find colonic polyps as well as a regular colonoscopy in people aged 45-75 who are already scheduled for the procedure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: Capso Vision, Inc. (industry)
• Drugs / interventions: radiation
• Locations: 14 sites (Lancaster, California and 13 other locations)
• Trial ID: NCT04607746 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for detecting colonic polyps, using traditional colonoscopy as a reference standard. Participants aged 45-75 who are already scheduled for a colonoscopy will be recruited to undergo this new capsule endoscopy procedure. The study aims to determine how well the capsule can identify polyps compared to the standard colonoscopy results. Participants must consent to share their colonoscopy images and results with the study sponsor.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45-75 who are committed to undergoing a colonoscopy.

Not a fit: Patients with a history of certain gastrointestinal diseases or conditions that contraindicate capsule endoscopy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive method for detecting colonic polyps, improving patient comfort and compliance.

How similar studies have performed: Other studies have shown promise in using capsule endoscopy for gastrointestinal conditions, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. At least 45-75 years of age
2. Committed to undergo a colonoscopy, independent of this study
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 is of child-bearing potential and does not practice medically acceptable methods of contraception. 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

Where this trial is running

Lancaster, California and 13 other locations

• Gastro Care Institute — Lancaster, California, United States (RECRUITING)
• Kaiser Permanente Northern California — San Leandro, California, United States (RECRUITING)
• Advanced Research Institute — New Port Richey, Florida, United States (RECRUITING)
• Digestive Health Services — Downers Grove, Illinois, United States (RECRUITING)
• Northshore Center for Gastroenterology — Libertyville, Illinois, United States (RECRUITING)
• Suburban Gastroenterology — Naperville, Illinois, United States (RECRUITING)
• Southwest Gastroenterology — New Lenox, Illinois, United States (RECRUITING)
• West Michigan Clinical Research Center — Wyoming, Michigan, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• Hattiesburg GI Associates — Hattiesburg, Mississippi, United States (RECRUITING)
• Gastroenterology Group of Rochester — Rochester, New York, United States (RECRUITING)
• Great Lakes Gastroenterology Research — Mentor, Ohio, United States (RECRUITING)
• Tri-Cities Gastroenterology — Kingsport, Tennessee, United States (RECRUITING)
• Gastroenterology Consultants of SW Virginia — Roanoke, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: David Shields, MD — Private Practice
• Study coordinator: Rebecca Petersen

Conditions: Colonic Polyp