A Study to Evaluate the Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses

Overview

About this study

The primary purpose of this study is to evaluate the safety of the Check-Cap C-Scan System.

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Male or female at the age of 40-80 years old.
  • Subject provided signed informed consent. 
  • Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone. 
  • Subjects able and agrees to undergo colonoscopy procedure. 
  • BMI > 19 and ≤ 35. 
  • Maximum body (abdominal) circumference < 120 cm. 
  • Has at least 3 bowel movements per week.
  • A colonoscopy procedure is pre-scheduled within 60 days.

Exclusion Criteria:

  • Subject who is not a suitable candidate for a colonoscopy (i.e., moderate sedation).
  • Known history of dysphagia or other swallowing disorders.
  • History of the followings: Inflammatory Bowel Disease (IBD) including Crohn's disease or Ulcerative, Colitis, Meckel's Diverticulum, Bowen Hernia, known fistulas or strictures (doctors' discretion), or a history of small bowel obstruction.
  • Known motility disorders:
    • Chronic constipation: less than 3 bowel movements/week, w/out the use of laxatives;
    • Delayed gastric emptying;
    • Narcotic use.
  • Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion with the exception of appendectomy, cholecystectomy and hysterectomy.
  • Any condition believed to have an increased risk for capsule retention, strictures, bowel adhesion or other obstacles to free passage of the capsule (such as intestinal tumors, radiation enteritis) or incomplete colonoscopies (e.g., due to obstructions or NSAID enteropathy) as determined by physician discretion.
  • Has a cardiac device (e.g., pacemaker or ICD-Implantable Cardioverter Defibrillator) or any other active implanted device.
  • Known sensitivity to iodine, or with known kidney failure.
  • Known condition which precludes compliance or is contraindicated with study and/or device instructions.
  • Has a Magnetic Image Resonance (MRI) procedure scheduled within 1 month.
  • Known condition of drug abuse and/or alcoholism.
  • 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.
  • Concurrent participation in another clinical trial using any investigational drug or device.

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.

Closed for enrollment

Contact information:

Crystal Lavey CCRP

(507)538-1361

Lavey.Crystal@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20455893

Mayo Clinic Footer