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Completed

NCT Number: NCT01364610

An Assessment of pH Testing Methods

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 - 75 years
  • Able to provide written consent
  • Symptoms potentially due to acid reflux and referred for an ambulatory pH study as part of routine clinical care
  • Able and willing to potentially undergo peroral Bravo placement
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study

Exclusion criteria

  • Previous esophageal surgery, or any known anatomic or functional defect of the digestive tract that might make capsule passage or retrieval unsafe
  • Clinical evidence (including physical exam and/or EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
  • Allergy to topical anesthetic
  • Any implanted electrical device such as a pacemaker, defibrillator or neurostimulator
  • Pregnant or breast-feeding females

Treatment and study plan

Bravo

Device

Bravo pH Monitoring System sited manometrically.

Other names: Bravo pH Monitoring System

Standard Care

Device

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.

Primary outcomes

  1. Overall discomfort with standard vs. Bravo pH-metry.

    Time frame: 24 hours

    Mean overall discomfort from the pH-metry procedure between Group 1 (standard) and Group 2 (Bravo) as measured by questionnaire.

Secondary outcomes

  1. Success rate of Bravo capsule placement

    Time frame: 24 hours

    As defined by completion of the manometry to find the Bravo placement depth; completion of peroral Bravo placement; adequate deployment and adherence of the Bravo capsule to the esophageal mucosa for a minimum of 20 hours.

  2. Site specific discomfort of both siting and placement procedures

    Time frame: 24 hours

  3. Ability to do normal activities

    Time frame: 24 hours

  4. Time off work

    Time frame: 24 hours

    Difference in recorded time off work for Group 1 (standard) vs. Group 2 (Bravo)

  5. Procedure Related Costs

    Time frame: 24 hours

    Procedure related costs between groups (including primary payer and societal costs)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

A Prospective Assessment of pH Testing Methods in Alberta

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jun 2, 2011
Registry last updated
Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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