MA-76: PillCam® ESO 2 in Esophageal Pathologies

Sponsor

Medtronic - MITG (Industry)

Overall Status

Completed

CT.gov ID

NCT00885469

Collaborator

(none)

101

Enrollment

Locations

Duration (Months)

10.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus Gastroesophageal Reflux Disease

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).

Study Design

Study Type:

Observational

Actual Enrollment :

101 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of PillCam® ESO 2 in Patients With Suspected Esophageal Pathologies

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
1 Patients with known Barrett's Esophagus or chronic GERD

Outcome Measures

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. [7 days]

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. [7 days]
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. [7 days]
Subjects' satisfaction will be assessed by a post procedure questionnaire [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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
5	Mayo Clinic	Rochester	Minnesota	United States	55905
6	Department of VA Medical Affairs Medical Center of Kansas City	Kansas City	Missouri	United States	66160
7	New York Gastroenterology Assoicates	New York	New York	United States	10021
8	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
9	Oregon Health & Science University	Portland	Oregon	United States	97239-3098
10	Virginia Mason Medical Center	Seattle	Washington	United States	98101

Sponsors and Collaborators

Medtronic - MITG

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