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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268406
• Other study ID #: CL-SY-01-0099
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2022
• Source: Check-Cap Ltd.
• Contact: Hanit Brenner- Lavie, PhD
• Phone: 97248303401
• Email: hanit.brenner[@]check-cap.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula
Israel	Soroka Medical Center	Be'er Sheva
Israel	Bnei Zion Medical center	Haifa
Israel	Lin- Clalit	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Talpiot- Clalit	Jerusalem
Israel	Meir Medical Center	Kefar Saba
Israel	Galil Medical Center	Nahariya
Israel	Laniado Medical Center	Netanya
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Check-Cap Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the ability of the C-Scan System to identify elevated risk subjects	Sensitivity for detecting subjects with elevated risk for polyps	60 days
Primary	Determine the ability of the C-Scan System to identify elevated risk subjects	Specificity for detecting subjects with elevated risk for polyps	60 days
Secondary	Incidence of device or procedure related adverse events	Analysis of safety data	Up to 7 days post C-Scan procedure completion
Secondary	Satisfaction with the C-Scan procedure assessed by a questionnaire	Satisfaction questionnaire to be completed by the subject	Up to 7 days post C-Scan procedure completion
Secondary	Satisfaction with the C-Scan procedure compared to colonoscopy assessed by a questionnaire	Satisfaction questionnaire to be completed by the subject	Up to 7 days post colonoscopy
Secondary	Evaluate the Whole Gut Transit Time	Time elapsed from capsule ingestion to excretion	During the C-Scan procedure