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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00481949 |
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Date of registration:
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01/06/2007 |
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Primary sponsor: |
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Public title:
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Assessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo
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Scientific title:
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What is the Physiologic and Clinical Relevance of Oesophagogastric Junction Distensibility? Studies Using Endo-Flip and 96 Hour Wireless pH System |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00481949 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Mark Fox, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Honorary Consultant and Senior Lecturer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Provision of written, fully informed consent to undergo mechanistic procedures:
Endo-FLIP, endoscopy and biopsy, 4 day wireless pH monitoring by the Bravo system
- All subjects should be off acid suppression medication (e.g. PPI, H2RA) for at least
5 days prior to endoscopy
Exclusion Criteria:
- Significant gastrointestinal symptoms or disease other than reflux
- Previous upper GI surgery or interventions such as oesophageal dilatations
- Predominant symptoms of motility disorders, e.g. dysphagia
- Presence of major oesophageal dysmotility on manometry, e.g. achalasia
- Significant co-morbidity requiring ongoing treatment or investigation
- Physical, neurological or psychiatric conditions preventing repeated visits to
hospital or compliance with study procedures (e.g. physical impairment/reduced
mobility)
- Pregnant at the time of enrolment
- No haematological abnormalities (no anticoagulants)
- No medications influencing gastrointestinal function within 3 days of the study.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastro-esophageal Reflux
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Heartburn
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Primary Outcome(s)
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Diagnostic reliability of prolonged wireless pH monitoring and comparison oesophago-gastric junction distensibility
[Time Frame: 1 year]
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Secondary Outcome(s)
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Prediction of treatment outcome with Endo-Flip and Bravo
[Time Frame: 2 years]
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Secondary ID(s)
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05/20702/84
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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