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

Capso Vision

Status: Completed

Conditions: Colonic Polyp

Treatments: Device: Capsule Endoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT04607746

CLN-CVI-5794

Details and patient eligibility

About

This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.

Full description

The first phase of the study investigated the first generation of the capsule. The second generation capsule will be investigated in the final phase of enrollment.

Enrollment: 1,337 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,337 participants in 1 patient group

Single arm study

Experimental group

Description:

Subjects swallows the investigational device and undergoes a colonoscopy

Treatment:

Device: Capsule Endoscope