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An Assessment of pH Testing Methods

A Prospective Assessment of pH Testing Methods in Alberta

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01364610
Enrollment
86
Registered
2011-06-02
Start date
2008-07-31
Completion date
2009-08-31
Last updated
2015-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

diagnosis, pH measurement, catheter, wireless

Brief 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.

Interventions

DEVICEBravo

Bravo pH Monitoring System sited manometrically.

DEVICEStandard 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

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall discomfort with standard vs. Bravo pH-metry.24 hoursMean overall discomfort from the pH-metry procedure between Group 1 (standard) and Group 2 (Bravo) as measured by questionnaire.

Secondary

MeasureTime frameDescription
Success rate of Bravo capsule placement24 hoursAs 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.
Site specific discomfort of both siting and placement procedures24 hours
Ability to do normal activities24 hours
Time off work24 hoursDifference in recorded time off work for Group 1 (standard) vs. Group 2 (Bravo)
Procedure Related Costs24 hoursProcedure related costs between groups (including primary payer and societal costs)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026