Ignite Creation Date:
2024-05-05 @ 11:36 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01364610
Status:
COMPLETED
Last Update Posted:
2015-06-22
First Post:
2011-05-31
Brief Title:
An Assessment of pH Testing Methods
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Prospective Assessment of pH Testing Methods in Alberta
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None