PillCam® ESO 2 in Esophageal Pathologies
Completed
Conditions studied: Barrett's Esophagus, Gastroesophageal Reflux Disease
In brief
Study Hypothesis: * PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis. * PillCam™ ESO will demonstrate all safety parameters as compared to EGD * PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD
Key facts
- Study ID
- NCT00885469
- Run by
- Medtronic - MITG
- People needed
- 101
- Starts
- 2007-12-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2019-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient age is 18 years or older
- Patient is known or suspected to suffer from an esophageal disease based on his/her medical history and recent symptoms suggestive of GERD or BE
- Patient agrees and signs the Informed Consent Form
- Currently taking PPI for at least 28 days.
You may not qualify if…
- Patient has dysphagia
- Patient has known Zenker's Diverticulum
- Patient is known or is suspected to suffer from esophageal and/or intestinal obstruction
- Patient has a cardiac pacemakers or other implanted electro medical devices
- Patient who has undergone an EGD within past seven days
- Female patient is pregnant and/or lactating
- Patient is expected to undergo Magnetic Resonance Imaging (MRI) examination within 7 days after ingestion of the capsule
- Patient has had a prior pelvic or abdominal surgery of the gastrointestinal tract (other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator such as appendectomy or uncomplicated cholecystectomy)
- Patient has any condition which precludes compliance with the study and/or device instructions
- Patient suffers from life threatening conditions
- Patient is currently participating in another clinical study
- Patient is on medications that may coat the esophagus such as iron or sulcrafate.
- Contraindication for any radiation or barium (e.g., sensitivity or allergy) required to confirm excretion of the capsule if necessary.
- Patient is currently suffering from conditions like allergy, illness (flu) or anything else that causes congestion, excessive salivation, etc. that could foster difficulty in swallowing the capsule or affect the clarity of the CE images.
- Contraindicated for use of laxatives, or surgery required to remove a capsule e.g., colonoscopy.
Where it is running
- Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
- University of Illinois at Chicago — Chicago, Illinois, United States
- Rockford Gastroenterolgy Assoicates — Rockford, Illinois, United States
- Minnesota Gastroenterology — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Department of VA Medical Affairs Medical Center of Kansas City — Kansas City, Missouri, United States
- New York Gastroenterology Assoicates — New York, New York, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Virginia Mason Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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