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

NCT05271656 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-07-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Check-Cap Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2023-07-26
Completion
2023-07-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271656 on ClinicalTrials.gov