Clinical trial NCT01364610: An Assessment of pH Testing Methods
Official title: A Prospective Assessment of pH Testing Methods in Alberta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: diagnosis
pH measurement
catheter
wireless
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall discomfort with standard vs. Bravo pH-metry.
timeFrame: 24 hours
Secondary outcomes:
measure: Success rate of Bravo capsule placement
timeFrame: 24 hours
measure: Site specific discomfort of both siting and placement procedures
timeFrame: 24 hours
measure: Ability to do normal activities
timeFrame: 24 hours
measure: Time off work
timeFrame: 24 hours
measure: Procedure Related Costs
timeFrame: 24 hours
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
citation: Andrews CN, Sadowski DC, Lazarescu A, Williams C, Neshev E, Storr M, Au F, Heitman SJ. Unsedated peroral wireless pH capsule placement vs. standard pH testing: a randomized study and cost analysis. BMC Gastroenterol. 2012 May 31;12:58. doi: 10.1186/1471-230X-12-58.