Status:
UNKNOWN
Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
Lead Sponsor:
Check-Cap Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
50-75 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05268406
Start Date
July 29 2020
End Date
August 31 2023
Last Update
December 8 2022
Active Locations (10)
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1
Emek Medical Center
Afula, Israel
2
Soroka Medical Center
Beersheba, Israel, 3030000
3
Bnei Zion Medical center
Haifa, Israel
4
Lin- Clalit
Haifa, Israel