Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single arm 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 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.
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Outcome Measures
Primary Outcome Measures
- Determine the ability of the C-Scan System to identify elevated risk subjects [60 days]
Sensitivity for detecting subjects with elevated risk for polyps
- Determine the ability of the C-Scan System to identify elevated risk subjects [60 days]
Specificity for detecting subjects with elevated risk for polyps
Secondary Outcome Measures
- Incidence of device or procedure related adverse events [Up to 7 days post C-Scan procedure completion]
Analysis of safety data
- Satisfaction with the C-Scan procedure assessed by a questionnaire [Up to 7 days post C-Scan procedure completion]
Satisfaction questionnaire to be completed by the subject
- Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire [Up to 7 days post colonoscopy]
Satisfaction questionnaire to be completed by the subject
- Evaluate the Whole Gut Transit Time [During the C-Scan procedure]
Time elapsed from capsule ingestion to excretion
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female at the age of 45-75 years old
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Able to provide a signed informed consent.
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Willing and able to comply with the specified study requirements and can be contacted by telephone.
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Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.*
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Maximum body (abdominal) circumference < 125 cm.
Exclusion Criteria:
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Subject who is not a suitable candidate for a colonoscopy
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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:
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Previous colon polyps
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Personal history of CRC
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Family history of CRC or adenomatous polyps diagnosed in a relative before age 60 years
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History of inflammatory bowel disease
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Having an inherited syndrome (Lynch syndrome, FAB)
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GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena
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Known motility disorders:
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Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
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Delayed gastric emptying.
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Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hour.
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Known IBD (Crohn's, ulcerative Colitis)
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Prior history of gastrointestinal tract surgery.
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Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion.
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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.
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Significant change in diameter and frequency of stool within the last 3 months
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Has an implanted cardiac device or any other implanted active device
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Known sensitivity to iodine or hyperthyroidism
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Acute kidney failure
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Known condition which precludes compliance or is contraindicated with study and/or device instructions.
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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
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Nuclear imaging procedure during 4 weeks before C-Scan procedure
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Known condition of opioid use disorder and/or alcoholism.
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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(
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Concurrent participation in another clinical trial using any investigational drug or device.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emek Medical Center | Afula | Israel | ||
| 2 | Soroka Medical Center | Be'er Sheva | Israel | 3030000 | |
| 3 | Bnei Zion Medical center | Haifa | Israel | ||
| 4 | Lin- Clalit | Haifa | Israel | ||
| 5 | Rambam Medical Center | Haifa | Israel | ||
| 6 | Talpiot- Clalit | Jerusalem | Israel | ||
| 7 | Meir Medical Center | Kefar Saba | Israel | ||
| 8 | Galil Medical Center | Nahariya | Israel | ||
| 9 | Tel Aviv Medical Center | Tel Aviv | Israel |
Sponsors and Collaborators
- Check-Cap Ltd.
Investigators
- Principal Investigator: Nadir Arber, Professor, Tel Aviv Medical Center, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CL-SY-01-0099