An Assessment of pH Testing Methods

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01364610
• Date of registration: 31/05/2011
• Primary sponsor: University of Calgary
• Public title: An Assessment of pH Testing Methods
• Scientific title: A Prospective Assessment of pH Testing Methods in Alberta
• Date of first enrolment: July 2008
• Target sample size: 86
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01364610
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

Canada

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Gastroesophageal Reflux

Intervention(s)

Device: Bravo

Device: Standard Care

Primary Outcome(s)

Overall discomfort with standard vs. Bravo pH-metry. [Time Frame: 24 hours]

Secondary Outcome(s)

Ability to do normal activities [Time Frame: 24 hours]

Procedure Related Costs [Time Frame: 24 hours]

Site specific discomfort of both siting and placement procedures [Time Frame: 24 hours]

Success rate of Bravo capsule placement [Time Frame: 24 hours]

Time off work [Time Frame: 24 hours]

Secondary ID(s)

Bravo

Source(s) of Monetary Support

Please refer to primary and secondary sponsors