Status:
COMPLETED
Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease
Lead Sponsor:
Nantes University Hospital
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients' quality of life. To alleviate symptoms and ease the healing of lesion, patients very often need to continu...
Eligibility Criteria
Inclusion
- Patient above 18 years old
- Suffering from typical symptoms of reflux (heartburn and/or acid regurgitation and/or epigastric burns with ascending radiations)
- Symptoms occurring at least 3 times a week without treatment
- Symptoms disappearing under full doses PPI treatment
- Requiring a continuous treatment for more than 3 months to get rid of symptoms (or nearly)
- Total consent signed from patient
Exclusion
- Contraindications to the radiofrequency technique:
- Columnar lined oesophagus ³ 3 cm height
- Barret's mucosa presenting dysplasia
- History of treated columnar lined oesophagus
- Hiatus hernia with a size over 3 cm
- History of Stage C or D esophagitis in the Los Angeles classification (18), or in progress
- History of oesophageal stenosis
- History of gastric or oesophageal surgery
- Presence of oesophageal and/or cardial varicose veins
- Presence of a cardiac pacemaker or implanted defibrillator (when confirmed by the manufacturer that use of RF energy will not interfere, it's ok to do patients!)
- Impossibility to interrupt a anticoagulant treatment or serious disorders of haemostasis
- General contraindications:
- Contraindication to general anaesthesia
- Existence of an associated serious disease making fear that the patient will live less than a year
- Incapacity to understand and sign a sensible consent of participation to the study
- Chronic alcoholism defined by a daily consumption of alcohol over 60 g
- Morbid obesity defined by a rate of body mass higher that 35
- Patients suffering from atypical GERD symptoms (especially extra-digestive) will not be included in the study if these symptoms are not associated with typical reflux symptoms (heartburn or regurgitation)
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00200642
Start Date
December 1 2003
End Date
October 1 2007
Last Update
May 22 2008
Active Locations (1)
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1
Nantes University Hospital
Nantes, France, 44093