REFER Registry
 |
|
| Dr. Bouvy performs the EsophyX ELF procedure. |
|
About the REFER Registry:
The REFER (Registry of EsophyX Fundoplications for Elimination of Reflux) Registry is a multi-center European registry for assessment of the outcomes and procedures of Endoluminal Fundoplication (ELF) using the EsophyX device for treatment of gastroesophageal reflux disease (GERD) or Non Erosive Reflux Disease (NERD).
All patients who meet inclusion/exclusion criteria and are treated with the EsophyX device from the time of CE mark approval (CE mark #99675) until December 31, 2006.
Overview of Registry:
The REFER Registry is a multi-center European registry for assessment of the outcomes and procedures of Endoluminal Fundoplication (ELF) using the EsophyX device for treatment of gastroesophageal reflux disease (GERD) or Non Erosive Reflux Disease (NERD). All consecutive patients who meet inclusion/exclusion criteria and are treated with the EsophyX device from the time of CE mark approval (CE mark #99675) until December 31, 2006 (with an option to continue enrollment after that time) at participating institutions will be enrolled. Outcomes are tracked at 6 months, 1 year and 2 years.
Objectives of Registry:
The objective of this registry is to investigate the safety and efficacy of Endoluminal Fundoplications (ELF) performed using the EsophyX device in commercial use at 20-30 thought leading European centers.
All patients treated with ELF procedures using the EsophyX device at participating institutions will be enrolled from the time of obtaining CE mark through December 31, 2006.
Study Design:
Since this is a registry assessing an EU approved product, every effort has been made to reduce the complexity of the study while still obtaining outcome data. Sites may wish to track additional data beyond that required by the protocol.
1. Screening Visit
2. Evaluation Visit
3. Procedure Visit (Day 0-1)
4. 6 months post-procedure visit (+/- 1 month)
5. 1 year post-procedure visit (+/- 2 months)
6. 2 year post-procedure visit (+/- 2 months)
Collections of Data:
The sponsor and Steering Committee take responsibility for the project, data analysis, supervision of data monitoring, communication and publication. Users meetings will be held on a regular basis to communicate results of the registry to investigators.
Quality Control:
The protocol will be implemented in accordance with Good Clinical Practices. The investigators will have periodic visits from the sponsor to verify the conduct of the study as well as compliance and patient safety criteria.
Contact:
Please contact us by clicking the link below.
PN C00659-01 Rev A
| 
