Study Stopped
Company no longer operational
EndoStim Patient Registry
RESTORE
1 other identifier
observational
350
7 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 15, 2024
October 1, 2024
6.4 years
May 1, 2015
October 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change in GERD-HRQL
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
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
Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
Change in antisecretory medication use
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)
Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years
- +3 more secondary outcomes
Study Arms (1)
EndoStim LES Stimulation System implant.
Registry subjects whom have been implanted commercially with the EndoStim LES Stimulation System device.
Interventions
Eligibility Criteria
Subjects with a diagnosis of GERD who are undergoing or have already undergone EndoStim LES stimulation system implantation.
You may qualify if:
- Subject meets therapy indications
- Subject signs informed consent
- Subject has a planned EndoStim LES Stimulation System implant (prospective) OR subject has already had EndoStim LES Stimulation System implant (retrospective)
You may not qualify if:
- \. Subject meets therapy contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EndoStim Inc.lead
Study Sites (30)
Fundacion Favaloro
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
Martha Maria Krankenhaus Halle-Dölau
Halle, Germany
Asklepios Klinik Altona
Hamburg, Germany
KRH Klinikum Siloah Hannover Oststadt
Hanover, Germany
Evangelisches Krankenhaus Herne
Herne, 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
München, 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, Germany
Hospital San José
Monterrey, Mexico
Maastricht University Medical Center
Maastricht, Netherlands
Spire Leicester Hospital
Leicester, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Related Publications (2)
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.
PMID: 22292889BACKGROUNDRodriguez 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.
PMID: 23073680BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Virender K Sharma, MD
EndoStim Inc.
- PRINCIPAL INVESTIGATOR
Joachim Labenz, MD
Diakonie Klinikum
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 12, 2015
Study Start
May 1, 2013
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share