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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2024
  • participants needed
    952
  • sponsor
    Check-Cap Ltd.
Updated on 20 June 2022
Accepts healthy volunteers

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 attached to the subject's back. Subjects then will be asked to swallow the C-Scan capsule and will be released from the clinic to their routine. Subjects will be asked to ingest contrast agent fluid and fiber pills starting 48 hours before capsule swallowing, up to capsule natural excretion.

Standard colonoscopy procedure will be performed within 60 days following the C-Scan Cap swallowing.

Details
Condition Healthy
Treatment C-Scan System
Clinical Study IdentifierNCT05271656
SponsorCheck-Cap Ltd.
Last Modified on20 June 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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