Evaluation of C-Scan capsule in identifying subjects with elevated risk of colon polyps

Brief description of study

The purpose of this study is to evaluate the effectiveness and safety of the Check-Cap C-Scan system. The C-Scan system is considered an investigational device because it is not Food and Drug Administration (FDA) approved for use outside of a research study. The C-Scan system does not require cleaning of the colon prior to the C-Scan Cap is swallowed and painlessly scans the colon to detect suspicious findings, such as colorectal polyps. Using the C-Scan system, suspicious findings that may be colorectal polyps can be identified before they become cancerous. The information gained using the C-Scan system will be compared to the information obtained during a follow-up optical colonoscopy procedure, scheduled as part of your routine screening.

Clinical Study Identifier: s22-00376
ClinicalTrials.gov Identifier: NCT05271656
Principal Investigator: Seth A. Gross.

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