Quality Assessment of Colon Capsule Endoscopy
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. 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:
- 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 the study team for the most up-to-date information regarding possible participation.
| 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