Quality Assessment of Colon Capsule Endoscopy

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-004603
    Sponsor Protocol Number: 14-004603

About this study

The primary aims of the study include determining the patient’s experience with colon capsule endoscopy (CCE) and the associated bowel preparation. In addition, the nursing staff experience with administration of the colon capsule will also be noted. Finally, the physician’s experience with interpretation of the colon capsule images. The secondary aim of this study is preliminary evaluation of the diagnostic yield of CCE compared to CT colonography (CTC).

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age > 18 years old
  • Subject to be outpatient status
  • Ability to give informed consent
  • Incomplete colonoscopy due to difficult anatomy or technical difficulty
  • Patients who will have underwent CTC after incomplete colonoscopy

Exclusion Criteria:

  • Allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation withPEG3350 (MoviPrep®), metoclopramide, senna, or SUPREP.
  • Pregnancy
  • Swallowing disorder (including impaired gag reflex)
  • History of aspiration
  • History of Zenker’s diverticulum
  • Patients with implantable cardiac devices
  • History of bowel strictures or fistulas
  • MRI scheduled within the next 2 weeks
  •  Age < 18 years old

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Rajan, M.D.

Closed for enrollment

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-20309522

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