EndoStim Patient Registry

GERD Clinical Trial

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Official title:

EndoStim Patient Registry-LES Stimulation System for the Treatment of GERD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02441400
• Other study ID #: CS500
• Status: Terminated
• Start date: May 2013
• Est. completion date: October 2019

Study information

• Verified date: September 2019
• Source: EndoStim Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 350
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GERD

Intervention

Device:
• EndoStim LES Stimulation System

Locations

Country	Name	City	State
Argentina	Fundacion Favaloro	Buenos Aires
Austria	University Hospital Vienna	Vienna
Denmark	Aarhus University Hospital	Aarhus
Germany	SANA Klinikum Lichtenberg	Berlin
Germany	Evangelisches Krankenhaus Castrop-Rauxel	Castrop Rauxel
Germany	St. Marienstift Krankenhaus Friesoythe	Friesoythe
Germany	Hospital zum Heiligen Geist Fritzlar	Fritzlar
Germany	Klinikum Garmisch-Partenkirchen	Garmisch-Partenkirchen
Germany	Wolfartklinik Graefelfing	Gräfelfing
Germany	Martha Maria Krankenhaus Halle-Dölau	Halle
Germany	Asklepios Klinik Altona	Hamburg
Germany	KRH Klinikum Siloah Hannover Oststadt	Hannover
Germany	Evangelisches Krankenhaus Herne	Herne
Germany	Heilig Geist-Krankenhaus Köln	Köln
Germany	Klinikum Konstanz	Konstanz
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Klinikum Memmingen	Memmingen
Germany	Klinikum Minden Johannes Wesling	Minden
Germany	Klinikum Muenchen Bogenhausen	Muenchen
Germany	Friedrich-Ebert-Krankenhaus Neumünster	Neumünster
Germany	Asklepios Schwalm-Eder Kliniken GmbH	Schwalmstadt
Germany	Jung Stilling - Siegen	Siegen
Germany	St. Marien-Krankenhaus Siegen	Siegen
Germany	Klinikum Stuttgart, Krankenhaus Bad Cannstatt	Stuttgart
Germany	Ev. Krankenhaus Wesel GmbH	Wesel
Mexico	Hospital San José	Monterrey
Netherlands	Maastricht University Medical Center	Maastricht
United Kingdom	Spire Leicester Hospital	Leicester
United Kingdom	University Hospital Southampton	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
EndoStim Inc.

Countries where clinical trial is conducted

Argentina,  Austria,  Denmark,  Germany,  Mexico,  Netherlands,  United Kingdom, 

References & Publications (2)

Rodríguez L, Rodriguez P, Gómez 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. — View Citation

Rodríguez L, Rodríguez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events	Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up	5 years post-implant
Secondary	Change in GERD-HRQL	Change from baseline GERD-HRQL	Various timepoints
Secondary	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	Various timepoints
Secondary	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)	Various timepoints
Secondary	Change in antisecretory medication use	Change from baseline in antisecretory medication use	Various timepoints
Secondary	Change in Structured GI Questionnaire responses (vs. baseline)	Change from baseline on Structured GI Questionnaire responses	Various timepoints
Secondary	Change in sleep related quality of life	Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index)	Various timepoints
Secondary	Change in work productivity impairment	Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire)	Various timepoints
Secondary	Change in Reflux Disease Questionnaire (RDQ) scores	Change from baseline in RDQ scores	Various timepoints

External Links

•   Registry sponsor's website