Description:

ODM derived from http://clinicaltrials.gov/show/NCT00291746

Link:

http://clinicaltrials.gov/show/NCT00291746

Keywords:
Versions (2) ▾
  1. 3/6/12
  2. 8/4/15
Uploaded on:

August 4, 2015

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY 4.0
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Eligibility Gastroesophageal Reflux NCT00291746

Eligibility Gastroesophageal Reflux NCT00291746

Inclusion Criteria
Age 18 Years to 79 Years
Subjects who seek medical advice at their family doctor (primary care physician) for symptoms thought by the primary care physician to arise from the upper GI tract
The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1
Exclusion Criteria
Upper GI endoscopy performed within a year prior to Visit 1
Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
Contra-indication to the BravoTM procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with severe esophagitis (grade D) confirmed by endoscopy at Visit 2 can continue the study without performing the BravoTM procedure)
Medical Concepts