NCT05268406

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Check-Cap Ltd. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the first part of the study (subgroup R\&D) is to demonstrate the safety and performance of the C-Scan system and to collect data in order to improve the analysis process. The purpose of the second part of the study (subgroup pre-pivotal) is to determine the ability of the C-Scan System to identify elevated risk subjects

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	C-Scan System	Subjects will be provided with contrast agent and dietary fiber pills, and instructed to start intake approximately 48 hours prior to the planned C-Scan procedure start. 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: 2020-07-29
• Primary completion: 2023-05-31
• Completion: 2023-08-31
• First posted: 2022-03-07
• Last updated: 2022-12-08

Locations

10 sites across 1 country: Israel