An Assessment of pH Testing Methods

Summary

Gastroesophageal reflux disease (GERD) is a common and potentially debilitating disorder. Typical symptoms include heartburn and regurgitation of acid tasting substances. GERD is a chronic disease and in some cases, more alarming symptoms including food sticking in the esophagus, pain with swallowing, bleeding, anemia and weight loss develop.

In Alberta, upper endoscopy is the first line of investigation accompanied by an ambulatory 24-hour esophageal pH monitoring for patients with symptoms that are unresponsive to acid-suppressing therapy or who exhibit alarm symptoms.

Current standard of care in Alberta for esophageal pH monitoring first requires an esophageal manometry test to identify the location of the lower esophageal sphincter followed by the placement of a thin catheter with one or more pH probes inserted through the nose and taped in place to the face for 20 -24 hours. The patient wears a small battery powered data logger and maintains a diary of GERD symptoms and activity. This system enables the recording and correlation of specific symptoms with reflux episodes over extended periods and provides direct evidence of GERD. The nasally passed pH catheter is uncomfortable and restrictive for some patients often resulting in abnormal eating, drinking, activity and sleeping patterns. The data collected may not be representative of the patient's typical experience and may not reflect the true severity of the disease.

A wireless diagnostic pH monitoring system called Bravo pH Monitoring System developed by Medtronic is approved for use in Canada and is commercially available. This system eliminates the need for a catheter by utilizing a capsule the size of a gel-cap and radio frequency technology to monitor esophageal pH. It has been shown to be safe and as sensitive as conventional catheter-based pH probe monitoring. The Bravo system can be sited either endoscopically or manometrically.

The goal of this study is to test the Bravo Wireless pH system in Alberta using manometric siting to assess feasibility, patient outcomes and tolerance.

Hypotheses:

1. Patient tolerance of the Bravo system is superior to standard pH-metry.
2. Manometric placement of Bravo is as successful as standard pH-metry.

Our aims:

1. To assess patient tolerance of Bravo versus standard pH-metry.
2. To compare the success rate of manometric peroral placement of Bravo pH probe versus standard pH-metry.

Conditions

• Gastroesophageal Reflux

Interventions

DEVICE

Bravo

Bravo pH Monitoring System sited manometrically.

DEVICE

Standard Care

Nasally passed pH catheter sited by manometry, accompanied by battery powered data logger. Participant activated event marker in response to symptoms, meals and body position changes.

Sponsors & Collaborators

• University of Calgary

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2008-12-31

Completion

2009-08-31

Countries

• Canada

Study Locations