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

Check-Cap

Status: Unknown

Conditions: Healthy Subjects

Treatments: Device: C-Scan System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05268406

CL-SY-01-0099

Details and patient eligibility

About

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

Enrollment: 800 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female at the age of 50-75 years old
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

1. Subject who is not a suitable candidate for a colonoscopy

2. Known history of dysphagia or other swallowing disorders.

   Third (3rd) and fourth (4th) exclusion criteria are applicable to the pre-pivotal subgroup only:

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

Single arm

Experimental group

Description:

All study participants will undergo the C-Scan System procedure, followed by a standard of care optical colonoscopy

Treatment:

Device: C-Scan System