An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
Summary
The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease.
Description
The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Gastroesophageal Reflux Disease
Intervention
Gatekeeper Reflux Repair System
Location
Contact Medtronic for specific site information
San Francisco
California
United States
94115
Status
Terminated
Source
MedtronicNeuro
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00200044
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bile Reflux
Retrograde bile flow. Reflux of bile can be from the duodenum to the stomach (DUODENOGASTRIC REFLUX); to the esophagus (GASTROESOPHAGEAL REFLUX); or to the PANCREAS.
Eosinophilic Esophagitis
Chronic ESOPHAGITIS characterized by esophageal mucosal EOSINOPHILIA. It is diagnosed when an increase in EOSINOPHILS are present over the entire esophagus. The reflux symptoms fail to respond to PROTON PUMP INHIBITORS treatment, unlike in GASTROESOPHAGEAL REFLUX DISEASE. The symptoms are associated with IgE-mediated hypersensitivity to food or inhalant allergens.
Cisapride
A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed)
Esophageal Motility Disorders
Disorders affecting the motor function of the UPPER ESOPHAGEAL SPHINCTER; LOWER ESOPHAGEAL SPHINCTER; the ESOPHAGUS body, or a combination of these parts. The failure of the sphincters to maintain a tonic pressure may result in gastric reflux of food and acid into the esophagus (GASTROESOPHAGEAL REFLUX). Other disorders include hypermotility (spastic disorders) and markedly increased amplitude in contraction (nutcracker esophagus).
Regurgitation, Gastric
GASTROESOPHAGEAL REFLUX wherein the retrograde flow passes through the UPPER ESOPHAGEAL SPHINCTER
Clinical Trials
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux diseas...
Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule
The purpose of this research is to study the level of acid exposure above the gastroesophageal junction and the distal esophagus in patients with reflux symptoms using a capsule type acid...
Validation of RDQ Questionnaire
The primary objective of this study is to determine the accuracy of the Reflux Disease Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom evaluation by t...
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux di...
The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroe...
PubMed Articles
Gastroesophageal reflux disease in children.
Reflux of gastric contents is common in young infants but usually self-limiting and not pathological. Gastroesophageal reflux disease refers to persistent reflux due to pathological factors that resul...
Cough and laryngo-pharyngeal symptoms (LPS) are associated with gastroesophageal reflux disease (GERD). The role of acid reflux (AR) and non-acid reflux (NAR) in atypical GERD pathogenesis is cont...
Enhanced endoscopic imaging and gastroesophageal reflux disease.
Gastroesophageal reflux disease (GERD) and GERD-related symptoms are common, and affect 25% to 30% of the general population. Upper gastrointestinal endoscopy of the esophagus has been the most widely...
BACKGROUND: There is controversy about the tailored or routine addition of an antireflux fundoplication in large hiatal hernia (type II-IV) repair. We investigated the strategy of selective addition o...
INTRODUCTION: We studied the inter-relationships of endoscopic findings around the gastroesophageal junction in patients with symptomatic gastroesophageal reflux. METHODS: Data were collected with reg...
