Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
NCT ID: NCT05268406
Last Updated: 2022-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
800 participants
INTERVENTIONAL
2020-07-29
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Single arm
All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Able to provide a signed informed consent.
3. Willing and able to comply with the specified study requirements and can be contacted by telephone.
4. Scheduled for colonoscopy procedure within 60 days of C-Scan ingestion within the research institution's system.\*
5. Maximum body (abdominal) circumference \< 125 cm.
Exclusion Criteria
2. Known history of dysphagia or other swallowing disorders.
3. 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)
4. GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena
5. Known motility disorders:
1. Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
2. Delayed gastric emptying.
3. Ongoing diarrhea defined as passage of loose or watery stools at least three times in a 24-hour.
6. Known IBD (Crohn's, ulcerative Colitis)
7. Prior history of gastrointestinal tract surgery.
8. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion.
9. 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.
10. Significant change in diameter and frequency of stool within the last 3 months
11. Has an implanted cardiac device or any other implanted active device
12. Known sensitivity to iodine or hyperthyroidism
13. Acute kidney failure
14. Known condition which precludes compliance or is contraindicated with study and/or device instructions.
15. 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
16. Nuclear imaging procedure during 4 weeks before C-Scan procedure
17. Known condition of opioid use disorder and/or alcoholism.
18. 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(
19. Concurrent participation in another clinical trial using any investigational drug or device.
50 Years
75 Years
ALL
Yes
Sponsors
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Check-Cap Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Nadir Arber, Professor
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center, Israel
Locations
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Emek Medical Center
Afula, , Israel
Soroka Medical Center
Beersheba, , Israel
Bnei Zion Medical center
Haifa, , Israel
Lin- Clalit
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Talpiot- Clalit
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Galil Medical Center
Nahariya, , Israel
Laniado Medical Center
Netanya, , Israel
Tel Aviv Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Ian Gralnek, Professor
Role: primary
Tova Rainis, M.D
Role: primary
Hisham Shuli, M.D
Role: primary
Elizabeth half, M.D
Role: primary
Yehuda Ringel, Professor
Role: primary
Wisam Sbeit, M.D
Role: primary
Other Identifiers
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CL-SY-01-0099
Identifier Type: -
Identifier Source: org_study_id
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