Clinical trial NCT00885469: PillCam® ESO 2 in Esophageal Pathologies
Official title: Evaluation of PillCam® ESO 2 in Patients With Suspected Esophageal Pathologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Gastroesophageal Reflux Disease
Keywords: known Barrett's Esophagus
Suspected Barrett's Esophagus
chronic GERD
known Barrett's Esophagus or chronic GERD
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with known Barrett's Esophagus or chronic GERD

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 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

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 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.

Primary outcomes:
measure: 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.
timeFrame: 7 days
Secondary outcomes:
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: Subjects' satisfaction will be assessed by a post procedure questionnaire
timeFrame: 7 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterolgy Assoicates
state: Illinois
city: Minneapolis
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Department of VA Medical Affairs Medical Center of Kansas City
state: Missouri
city: New York
country: United States
facility: New York Gastroenterology Assoicates
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Oregon Health and Science University
name: Glen Eisen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of VA Medical Affairs Medical Center of Kansas City
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: