Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200642
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2005-09-12
Brief Title:
Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2008-05
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 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 continuously take anti-secretory drugs Proton pump inhibitors or PPIs which despite their efficiency do not cure the disease For these PPI dependent patients an anti-reflux surgery fundoplication often made by coelioscopy is a possible alternative but it has a significant morbidity rate and even an estimated post-operative mortality of 08 outside of expertise centres Therefore new therapeutic endoscopic approaches supposed to be less invasive and less expensive than surgery have been developed during the last three years Among them radiofrequency Stretta procedure consists in administering a high frequency current in the cardia area in order to induce thanks to a thermal effect a sub-mucous remodelling and a modification of the compliance of the cardia regionThe aim of this project carried out in 8 French centres and 2 European centers is to assess through a randomised trial the efficiency of radiofrequency on PPI dependent patients The study will be carried out in 2 phases with patients who have been fully informed of the project statement and particularly of the potential risks of the radiofrequency technique and have given their written acceptation to participate to the studyThe first phase which will last 6 to 11 weeks will aim at making sure that patients are PPI dependent and define their needs After this initial phase patients will be randomised between those who will carry on with the PPI treatment or the radiofrequency treatment The follow up after this randomisation will last one year The first assessment of the therapeutic efficiency will be done at 6th month The 6 additional follow up months will be required for the assessment of mid-term side effects of the treatment and the rate of symptomatic recurrences
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