Clinical trial NCT02441400: EndoStim Patient Registry
Official title: EndoStim Patient Registry-LES Stimulation System for the Treatment of GERD
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: GERD
Keywords: GERD
LES Pressure
Electrical Stimulation
Lead sponsor: EndoStim Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of GERD who are undergoing or have already undergone EndoStim LES stimulation system implantation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject meets therapy indications
2. Subject signs informed consent
3. Subject has a planned EndoStim LES Stimulation System implant (prospective) OR subject has already had EndoStim LES Stimulation System implant (retrospective)

Exclusion Criteria:

1. Subject meets therapy contraindications

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 5 years post-implant
Secondary outcomes:
measure: Change in GERD-HRQL
timeFrame: Change in GERD-HRQL questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
measure: Comparison of pH values
timeFrame: 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
measure: Comparison of symptoms and quality of life
timeFrame: Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
measure: Change in antisecretory medication use
timeFrame: The use of antisecretory medication will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
measure: Change in Structured GI Questionnaire responses (vs. baseline)
timeFrame: Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
measure: Change in sleep related quality of life
timeFrame: Sleep related quality of life will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
measure: Change in work productivity impairment
timeFrame: Work productivity will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
measure: Change in Reflux Disease Questionnaire (RDQ) scores
timeFrame: RDQ questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro
city: Vienna
country: Austria
facility: University Hospital Vienna
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Berlin
country: Germany
facility: SANA Klinikum Lichtenberg
city: Castrop Rauxel
country: Germany
facility: Evangelisches Krankenhaus Castrop-Rauxel
city: Friesoythe
country: Germany
facility: St. Marienstift Krankenhaus Friesoythe
city: Fritzlar
country: Germany
facility: Hospital zum Heiligen Geist Fritzlar
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen
city: Gräfelfing
country: Germany
facility: Wolfartklinik Graefelfing
city: Halle
country: Germany
facility: Martha Maria Krankenhaus Halle-Dölau
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: KRH Klinikum Siloah Hannover Oststadt
city: Herne
country: Germany
facility: Evangelisches Krankenhaus Herne
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Köln
country: Germany
facility: Heilig Geist-Krankenhaus Köln
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Memmingen
country: Germany
facility: Klinikum Memmingen
city: Minden
country: Germany
facility: Klinikum Minden Johannes Wesling
city: Muenchen
country: Germany
facility: Klinikum Muenchen Bogenhausen
city: Neumünster
country: Germany
facility: Friedrich-Ebert-Krankenhaus Neumünster
city: Schwalmstadt
country: Germany
facility: Asklepios Schwalm-Eder Kliniken GmbH
city: Siegen
country: Germany
facility: Jung Stilling - Siegen
city: Siegen
country: Germany
facility: St. Marien-Krankenhaus Siegen
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart, Krankenhaus Bad Cannstatt
city: Wesel
country: Germany
facility: Ev. Krankenhaus Wesel GmbH
city: Monterrey
country: Mexico
facility: Hospital San José
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Leicester
country: United Kingdom
facility: Spire Leicester Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: EndoStim Inc.
name: Virender K Sharma, MD
role: STUDY_DIRECTOR
affiliation: Diakonie Klinikum
name: Joachim Labenz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez L, Rodriguez P, Neto MG, Ayala JC, Saba J, Berel D, Conklin J, Soffer E. Short-term electrical stimulation of the lower esophageal sphincter increases sphincter pressure in patients with gastroesophageal reflux disease. Neurogastroenterol Motil. 2012 May;24(5):446-50, e213. doi: 10.1111/j.1365-2982.2012.01878.x. Epub 2012 Jan 31.
citation: Rodriguez L, Rodriguez P, Gomez B, Ayala JC, Saba J, Perez-Castilla A, Galvao Neto M, Crowell MD. Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: final results of open-label prospective trial. Surg Endosc. 2013 Apr;27(4):1083-92. doi: 10.1007/s00464-012-2561-4. Epub 2012 Oct 17.