St Petersburg, FL

Advanced Research Institute, Inc.

Polyps

Colonic Polyps

Capso Vision

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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

Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

Advanced Research Institute, Inc. | St Petersburg, FL

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Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

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