Gastroesophageal RefluxNCT01364610
An Assessment of pH Testing Methods
A study testing Bravo in people with Gastroesophageal Reflux, run by University of Calgary at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Bravo
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta
Edmonton, Alberta
About this study
Official title: A Prospective Assessment of pH Testing Methods in Alberta
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.
Read more
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:
- Patient tolerance of the Bravo system is superior to standard pH-metry.
- Manometric placement of Bravo is as successful as standard pH-metry.
Our aims:
- To assess patient tolerance of Bravo versus standard pH-metry.
- To compare the success rate of manometric peroral placement of Bravo pH probe versus standard pH-metry.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Bravo, Standard Care
- Keywords
- diagnosis, pH measurement, catheter, wireless
- Medical subject headings
- Gastroesophageal Reflux, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BravoDevice
Also called Bravo pH Monitoring System
Bravo pH Monitoring System sited manometrically.
Standard CareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bravo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (5)
Success rate of Bravo capsule placement
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.
Measured: 24 hours
Site specific discomfort of both siting and placement procedures
Measured: 24 hours
Ability to do normal activities
Measured: 24 hours
Time off work
Difference in recorded time off work for Group 1 (standard) vs. Group 2 (Bravo)
Measured: 24 hours
Procedure Related Costs
Procedure related costs between groups (including primary payer and societal costs)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Andrews, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364610
- Sponsor's protocol ID
- Bravo
- Status last verified
- Jun 2015
- First submitted
- 31 May 2011
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22650250
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Assessment of pH Testing Methods in Alberta
- ClinicalTrials.gov ID
- NCT01364610
- Acronym / sponsor ID
- Bravo
- Conditions
- Gastroesophageal Reflux
- Keywords
- diagnosis, pH measurement, catheter, wireless
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patient tolerance of the Bravo system is superior to standard pH-metry.
- Manometric placement of Bravo is as successful as standard pH-metry.
Our aims:
- To assess patient tolerance of Bravo versus standard pH-metry.
- To compare the success rate of manometric peroral placement of Bravo pH probe versus standard pH-metry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Device: Standard CareGroup 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. |
| Bravo pH Monitoring System | Active comparator | Device: BravoGroup 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BravoAlso: Bravo pH Monitoring SystemBravo pH Monitoring System sited manometrically. | Device | Bravo pH Monitoring System |
| Standard CareNasally 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. | Device | Standard Care |
Primary outcome
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.
5 secondary outcomes
Success rate of Bravo capsule placement
Time frame: 24 hours
Site specific discomfort of both siting and placement procedures
Time frame: 24 hours
Ability to do normal activities
Time frame: 24 hours
Time off work
Time frame: 24 hours
Procedure Related Costs
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Derived from this study: PubMed 22650250Andrews 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bravo in people with Gastroesophageal Reflux, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall discomfort with standard vs. Bravo pH-metry. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01364610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.