Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT05271656
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT05271656
Study Brief:
Protocol Section:
NCT05271656