PillCam® ESO 2 in Esophageal Pathologies (MA-76)

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00885469
First received: April 20, 2009
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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

Condition
Barrett's Esophagus
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of PillCam® ESO 2 in Patients With Suspected Esophageal Pathologies

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of agreement (i.e. positive, negative and overall agreement parameters) between PillCam ESO 2 and standard EGD in classifying the Z-line following the ZAP score (Wallner et. al 2002), where Grades 0&I and grades II&III will be consolidated. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Accuracy Parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting Esophagitis as compared to standard EGD, using unblinded EGD as the reference standard. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Subjects' satisfaction will be assessed by a post procedure questionnaire [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: December 2007
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with known Barrett's Esophagus or chronic GERD

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, and less invasive diagnostic tool for evaluating GERD patients and screening for BE. Esophageal capsule endoscopy (ECE) is a novel technique that offers non-invasive evaluation of esophageal pathology in gastroesophageal reflux disease (GERD) patients. The potential benefits of screening patients by Capsule Endoscopy (CE) are several. Detection of esophageal pathology during CE could select a subgroup of patients for upper endoscopy avoiding the risks and costs of an upper endoscopy in the majority. Other benefits include convenience, ability to perform the test on an outpatient basis in less than 30 minutes, patient acceptability, minimal loss of work time, safety, tolerability, the ability of non-physicians to screen patients, and potentially, improved compliance with screening recommendations. Recently, a new, high resolution capsule (ESO 2) with a larger field of view and better illumination than the previous CE has been introduced. A simplified ingestion protocol for CE that improves visualization of the Z-line has also been reported as well (17).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with known Barrett's Esophagus or chronic GERD

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885469

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Rockford Gastroenterolgy Assoicates
Rockford, Illinois, United States, 61107
United States, Minnesota
Minnesota Gastroenterology
Minneapolis, Minnesota, United States, 55446
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Department of VA Medical Affairs Medical Center of Kansas City
Kansas City, Missouri, United States, 66160
United States, New York
New York Gastroenterology Assoicates
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Glen Eisen, MD Oregon Health and Science University
Principal Investigator: Prateek Sharma, MD Department of VA Medical Affairs Medical Center of Kansas City
  More Information

No publications provided

Responsible Party: Hila Debby -Corporate Clinical Trials Manager, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00885469     History of Changes
Other Study ID Numbers: MA-76
Study First Received: April 20, 2009
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Given Imaging Ltd.:
known Barrett's Esophagus
Suspected Barrett's Esophagus
chronic GERD
known Barrett's Esophagus or chronic GERD

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on July 29, 2014