An interventional study of C-Scan System in Healthy, sponsored by Check-Cap Ltd.. Terminated at 3 sites in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by Check-Cap Ltd. · Not applicable, Interventional, and Screening
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.
318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.
This study's enrollment of 23 is below the median of 270 across 215 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Check-Cap Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of the following:
Known motility disorders:
All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy
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.
Also known as: Optical colonoscopy
Demonstrate the accuracy of the C-Scan system in identifying subjects with colon polyps comparing to optical colonoscopy (OC).
For each subject the primary efficacy endpoints are dichotomous diagnosis using the C-Scan device (Test) and optical colonoscopy (Reference standard). Reference standard will be considered "positive" ("1") if at least one polyp of at least 6 mm is found. Test will be considered with elevated risk for polyps ("1") if either at least one polyp of at least 6 mm is found or long WGTT\* occurred. The above endpoints will be used to calculate sensitivity and specificity examined in the primary analysis. \*Long WGTT is defined as more than 73 hours for male and more than 97 hours for female.
Time frame: 60 days
Negative predictive value for ruling out polyps of at least 10 mm.
Reference standard will be considered "positive" ("1") if at least one polyp of at least 10 mm is found.
Time frame: 60 days
Sensitivity of C-Scan for detecting polyps of at least 10mm.
Reference standard will be considered "positive" ("1") if at least one polyp of at least 10 mm is found.
Time frame: 60 days
Demonstrate the safety of the C-Scan System
Frequency of patients who experienced device or procedure related serious adverse events up to 7±3 days from capsule excretion. In addition, AEs and SAEs will be presented by severity and relation to device and procedure.
Time frame: 7±3 days from capsule excretion
Demonstrate subjects' satisfaction and usability with the C-Scan System
This will be assessed via a descriptive analysis using a questionnaire
Time frame: 7±3 days from capsule excretion
Demonstrate subjects' satisfaction with the C-Scan System compared to optical colonoscopy
This will be assessed via a descriptive analysis using a questionnaire
Time frame: 4-10 days post colonoscopy
Plan to share: Undecided
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Check-Cap Ltd.