An Assessment of pH Testing Methods

NCT01364610 | Completed

• 1 other identifier: Bravo
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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. 1.Patient tolerance of the Bravo system is superior to standard pH-metry.
2. 2.Manometric placement of Bravo is as successful as standard pH-metry.
3. 3.To assess patient tolerance of Bravo versus standard pH-metry.
4. 4.To compare the success rate of manometric peroral placement of Bravo pH probe versus standard pH-metry.

Conditions

Gastroesophageal Reflux

Keywords

diagnosis; pH measurement; catheter; wireless

Outcome Measures

Primary Outcomes (1)

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

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

  24 hours

Secondary Outcomes (5)

• Success rate of Bravo capsule placement

  24 hours

• Site specific discomfort of both siting and placement procedures

  24 hours

• Ability to do normal activities

  24 hours

• Time off work

  24 hours

• Procedure Related Costs

  24 hours

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Group 1 will have standard catheter based pH-metry. All participants will answer a questionnaire assessing tolerance and satisfaction of both the siting and placement methods and the 24 hour monitoring period.

Device: Standard Care

Bravo pH Monitoring System

ACTIVE COMPARATOR

Group 2 will undergo unsedated peroral placement of the Bravo capsule. All participants will answer a questionnaire assessing tolerance and satisfaction of both the siting and placement methods and the 24 hour pH monitoring period.

Device: Bravo

Interventions

Bravo DEVICE

Bravo pH Monitoring System sited manometrically.

Also known as: Bravo pH Monitoring System

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.

Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (1)

• 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.

  PMID: 22650250 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Disease

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: June 22, 2015

Record last verified: 2015-06

Locations

CA (2)