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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.
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Inclusion criteria
Exclusion criteria
Subject who is not a suitable candidate for a colonoscopy
Known history of dysphagia or other swallowing disorders.
History of the following:
Known motility disorders:
Known IBD (Crohn's, Ulcerative Colitis)
Prior history of gastrointestinal tract surgery.
Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by a physician
Any condition believed to have an increased risk for capsule retention, known strictures, known bowel adhesion or 'obstacles' to free passage of the capsule (such as esophageal diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by a physician.
Significant change in diameter and frequency of stool within the last 3 months.
GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena.
Implanted cardiac device or any other implanted active device
Known sensitivity to iodine
Acute kidney failure
Known condition which precludes compliance or is contraindicated with study and/or device instructions.
Any procedure requiring contrast agent, or which may introduce electronic interference (such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled within 14 days of C-Scan ingestion
Nuclear imaging procedure within the four (4) weeks preceding the C-Scan procedure.
Known condition of opioid use disorder and/or alcoholism.
Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization).
Concurrent participation in another clinical trail using any investigational drug or device.
Previous colonoscopy performed five (5) years or less before date of enrolment
Subjects who tend to hyperhidrosis in the back area
Primary purpose
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Interventional model
Masking
23 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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