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

Study Overview
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Brief Summary
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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

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Device: C-Scan System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female at the age of 50-75 years old Able to provide a signed informed consent. Willing and able to comply with the specified study requirements and can be contacted by telephone. Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.* Maximum body (abdominal) circumference < 125 cm. Exclusion Criteria: Subject who is not a suitable candidate for a colonoscopy Known history of dysphagia or other swallowing disorders. Third (3rd) and fourth (4th) exclusion criteria are applicable to the pre-pivotal subgroup only: History of the following: Previous colon polyps Personal history of CRC Family history of CRC or adenomatous polyps diagnosed in a relative before age 60 years History of inflammatory bowel disease Having an inherited syndrome (Lynch syndrome, FAB) GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena Known motility disorders: Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months. Delayed gastric emptying. Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hour. 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 physician discretion. Any condition believed to have an increased risk for capsule retention, known strictures, any prior episode of bowel obstruction: known bowel adhesion, any 'obstacles' to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies or incomplete colonoscopies as determined by physician discretion. Significant change in diameter and frequency of stool within the last 3 months Has an implanted cardiac device or any other implanted active device Known sensitivity to iodine or hyperthyroidism Acute kidney failure Known condition which precludes compliance or is contraindicated with study and/or device instructions. Has 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 during 4 weeks before 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 trial using any investigational drug or device.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy | Device: C-Scan System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the ability of the C-Scan System to identify elevated risk subjects | Sensitivity for detecting subjects with elevated risk for polyps | 60 days | 
| Determine the ability of the C-Scan System to identify elevated risk subjects | Specificity for detecting subjects with elevated risk for polyps | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device or procedure related adverse events | Analysis of safety data | Up to 7 days post C-Scan procedure completion | 
| Satisfaction with the C-Scan procedure assessed by a questionnaire | Satisfaction questionnaire to be completed by the subject | Up to 7 days post C-Scan procedure completion | 
| Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire | Satisfaction questionnaire to be completed by the subject | Up to 7 days post colonoscopy | 
| Evaluate the Whole Gut Transit Time | Time elapsed from capsule ingestion to excretion | During the C-Scan procedure |