Clinical trial NCT05271656: Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Official title: Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Check-Cap Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 23
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness.

During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion.

A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.


Eligibility criteria: Inclusion Criteria:

1. Subjects 45-75 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 no later than 60 days after C-Scan ingestion
5. Maximal 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.
3. History of the following:

   1. Colorectal polyps
   2. A personal history of CRC
   3. A family history of CRC or adenomatous polyps diagnosed in a relative before 60 years of age
   4. A history of inflammatory bowel disease of significant duration
   5. One of two (2) hereditary syndromes
4. Known motility disorders:

   1. Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months.
   2. Ongoing diarrhea defined as passage of loose or watery stools at least three times within 24-hour
   3. Delayed gastric emptying.
5. Known IBD (Crohn's, Ulcerative Colitis)
6. Prior history of gastrointestinal tract surgery.
7. Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by a physician
8. Any condition believed to have an increased risk for capsule retention, known strictures, known bowel adhesion or 'obstacles' to free passage of the capsule (such as esophageal diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by a physician.
9. Significant change in diameter and frequency of stool within the last 3 months.
10. GI bleeding within the last 3 months i.e., rectal outlet bleeding, hematochezia or melena.
11. Implanted cardiac device or any other implanted active device
12. Known sensitivity to iodine
13. Acute kidney failure
14. Known condition which precludes compliance or is contraindicated with study and/or device instructions.
15. 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 within the four (4) weeks preceding the 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 trail using any investigational drug or device.
20. Previous colonoscopy performed five (5) years or less before date of enrolment
21. Subjects who tend to hyperhidrosis in the back area

Primary outcomes:
measure: Demonstrate the accuracy of the C-Scan system in identifying subjects with colon polyps comparing to optical colonoscopy (OC).
timeFrame: 60 days
Secondary outcomes:
measure: Negative predictive value for ruling out polyps of at least 10 mm.
timeFrame: 60 days
measure: Sensitivity of C-Scan for detecting polyps of at least 10mm.
timeFrame: 60 days
measure: Demonstrate the safety of the C-Scan System
timeFrame: 7±3 days from capsule excretion
measure: Demonstrate subjects' satisfaction and usability with the C-Scan System
timeFrame: 7±3 days from capsule excretion
measure: Demonstrate subjects' satisfaction with the C-Scan System compared to optical colonoscopy
timeFrame: 4-10 days post colonoscopy
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
References: