Clinical trial NCT05268406: Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
Official title: Evaluation of C-Scan in Identifying Subjects With Elevated Risk of Polyps in the Colon
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Check-Cap Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 800
Sex: ALL
Minimum age (years): 50
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 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


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the ability of the C-Scan System to identify elevated risk subjects
timeFrame: 60 days
measure: Determine the ability of the C-Scan System to identify elevated risk subjects
timeFrame: 60 days
Secondary outcomes:
measure: Incidence of device or procedure related adverse events
timeFrame: Up to 7 days post C-Scan procedure completion
measure: Satisfaction with the C-Scan procedure assessed by a questionnaire
timeFrame: Up to 7 days post C-Scan procedure completion
measure: Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire
timeFrame: Up to 7 days post colonoscopy
measure: Evaluate the Whole Gut Transit Time
timeFrame: During the C-Scan procedure
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnei Zion Medical center
city: Haifa
country: Israel
facility: Lin- Clalit
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Talpiot- Clalit
city: Kefar Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Galil Medical Center
city: Netanya
country: Israel
facility: Laniado Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center, Israel
name: Nadir Arber, Professor
role: PRINCIPAL_INVESTIGATOR
References: