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

Overview

About this study

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 attached to the subject's back. Subjects then will be asked to swallow the C-Scan capsule and will be released from the clinic to their routine. Subjects will be asked to ingest contrast agent fluid and fiber pills starting 48 hours before capsule swallowing, up to capsule natural excretion. Standard colonoscopy procedure will be performed within 60 days following the C-Scan Cap swallowing.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. Subjec

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/25/23. Questions regarding updates should be directed to the study team contact.

ts who tend to hyperhidrosis in the back area

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Rajan, M.D.

Contact us for the latest status

Contact information:

Crystal Lavey CCRP

(507) 538-1361

Lavey.Crystal@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jonathan Leighton, M.D.

Contact us for the latest status

Contact information:

Samantha Basch

(480) 301-6198

Basch.Samantha@mayo.edu

More information

Publications

Publications are currently not available