PillCam® ESO 2 in Esophageal Pathologies

NCT00885469 | Completed

• 1 other identifier: MA-76
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 10

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

1

Patients with known Barrett's Esophagus or chronic GERD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with known Barrett's Esophagus or chronic GERD

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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (10)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Rockford Gastroenterolgy Assoicates

Rockford, Illinois, 61107, United States

Location

Minnesota Gastroenterology

Minneapolis, Minnesota, 55446, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Department of VA Medical Affairs Medical Center of Kansas City

Kansas City, Missouri, 66160, United States

Location

New York Gastroenterology Assoicates

New York, New York, 10021, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Glen Eisen, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Prateek Sharma, MD

  Department of VA Medical Affairs Medical Center of Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: December 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 31, 2019

Record last verified: 2009-08

Locations

US (10)