A Study to Evaluate the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps Compared to Colonoscopy

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is anticipated that the data from this clinical trial will be used to support marketing authorizations to commercialize the CapsoCam® Colon (CV-3).

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:

  • Between the ages of 50 and 75 years old.
  • Subject meets at least one of the following criteria for increased risk for polyps:
    • Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test;
    • Older than 55 years of age, without prior history of colonoscopy;
    • Has had a positive colonoscopy ≥ 5 years prior to screening visit; and/or
    • Having at least two of the following risk factors:
      • Current smoker;
      • BMI of ≥ 30;
      • Family history (blood relative) of colorectal cancer;
      • Sedentary lifestyle;
      • Low fiber/ high fat diet
  • No contraindication for capsule endoscopy or colonoscopy.
  • Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion.
  • Choose to participate and must have signed the IRB-approved informed-consent document and agreed to release colonoscopy images and results report to Sponsor.

Exclusion Criteria:

  • History of negative colonoscopy within the last 10 years.
  • History of incomplete colonoscopy.
  • Impaired cardiac function assessed as greater than NYHA Class II.
  • History of small- or large-bowel obstructive condition.
  • Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis.
  • Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the patient at greater risk for capsule endoscope retention.
  • Unable to follow or tolerate fasting, bowel preparation, and other study procedures.
  • Known allergy to ingredients used in bowel preparation and boosters.
  • Daily and/or regular use of narcotics.
  • Known or suspected AIDS.
  • Uncompensated cirrhosis.
  • Prior abdominal radiation therapy.
  • Diagnosis of anorexia or bulimia.
  • History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion.
  • Known or suspected megacolon.
  • Scheduled to undergo MRI examination within 7 days after ingestion of the capsule.
  • Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis.
  • Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening.
  • Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study.
  • Are currently enrolled in, or participated in within the last 30 days, another clinical study.
  • Chronic constipation as defined by < 3 bowel movements per week for at least 3 months prior to Screening, or the use of routine laxatives (other than fiber) to attain regular bowel movements for at least 3 months prior to Screening.
  • History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jonathan Leighton, M.D.

Contact us for the latest status

Contact information:

Pooja Bhakta B.S.

(480) 301-4226

bhakta.pooja@mayo.edu

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

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20508602

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