Status:
COMPLETED
PillCam® ESO 2 in Esophageal Pathologies
Lead Sponsor:
Medtronic - MITG
Conditions:
Barrett's Esophagus
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Brief Summary
Study Hypothesis: * PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and gr...
Detailed Description
Upper endoscopy (EGD) is employed to diagnose BE; however, the cost and invasiveness of this diagnostic tool limits its utilization in many patients (17). There is a need for an alternative, simple, a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00885469
Start Date
December 1 2007
End Date
April 1 2009
Last Update
July 31 2019
Active Locations (10)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
3
Rockford Gastroenterolgy Assoicates
Rockford, Illinois, United States, 61107
4
Minnesota Gastroenterology
Minneapolis, Minnesota, United States, 55446