NCT05271656

Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Check-Cap Ltd. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness. During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion. A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	C-Scan System	Subjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake of fiber pills 5 days, and contrast agent 48 hours prior to scheduled C-Scan capsule ingestion. C-Scan system intervention includes ingestion of the C-Scan Cap and attachment of the C-Scan Track to the subject's lower back. The subject is required to keep the C-Scan Track attached to the lower back and to continue intake of contrast agent and dietary fiber pills until the C-Scan Cap's natural excretion. Standard of care optical colonoscopy will be performed within 60 days from the C-Scan Cap ingestion.

Timeline

• Start date: 2022-05-10
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2022-03-09
• Last updated: 2023-07-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study