An Assessment of pH Testing Methods
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

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.
    


Intervention name(s): Bravo; Standard Care
Intervention type(s): Device; Device
Intervention description(s): Bravo pH Monitoring System sited manometrically.; 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.
Other intervention name(s): Bravo pH Monitoring System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diagnosis; pH measurement; catheter; wireless