To provide a research tool enabling physicians to monitor long term clinical outcomes for patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES Stimulation System.
The EndoStim Patient Registry provides a framework for data collection on patients with GERD treated with the EndoStim LES Stimulation System. The primary objective is to provide a tool for participating physician investigators to collect and analyze outcomes data related to the use of the EndoStim LES Stimulation System. This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms paper or on-line.
Study Type
OBSERVATIONAL
Enrollment
350
Fundacion Favaloro
Incidence and severity of adverse events
Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up
Time frame: 5 years post-implant
Change in GERD-HRQL
Change from baseline GERD-HRQL
Time frame: Change in GERD-HRQL questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Comparison of pH values
Change from baseline in the following (while off PPI): % 24-hour esophageal pH\<4.0, and number of reflux events \>1 minute and \> 5 minutes
Time frame: The pH values of % 24-hour esophageal pH < 4.0, and the number of reflux events > 1 minute and > 5 minutes will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Comparison of symptoms and quality of life
Change from baseline in symptoms (measured by patient diary) and in quality of life (measured by SF-12)
Time frame: Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Change in antisecretory medication use
Change from baseline in antisecretory medication use
Time frame: The use of antisecretory medication will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Change in Structured GI Questionnaire responses (vs. baseline)
Change from baseline on Structured GI Questionnaire responses
Time frame: Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
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Buenos Aires, Argentina
University Hospital Vienna
Vienna, Austria
Aarhus University Hospital
Aarhus, Denmark
SANA Klinikum Lichtenberg
Berlin, Germany
Evangelisches Krankenhaus Castrop-Rauxel
Castrop-Rauxel, Germany
Heilig Geist-Krankenhaus Köln
Cologne, Germany
St. Marienstift Krankenhaus Friesoythe
Friesoythe, Germany
Hospital zum Heiligen Geist Fritzlar
Fritzlar, Germany
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany
Wolfartklinik Graefelfing
Gräfelfing, Germany
...and 20 more locations
Change in sleep related quality of life
Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index)
Time frame: Sleep related quality of life will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Change in work productivity impairment
Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire)
Time frame: Work productivity will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Change in Reflux Disease Questionnaire (RDQ) scores
Change from baseline in RDQ scores
Time frame: RDQ questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years