EndoStim Patient Registry (RESTORE)

October 16, 2019 updated by: EndoStim Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EndoStim LES Stimulation System implant.
Registry subjects whom have been implanted commercially with the EndoStim LES Stimulation System device.
Device: EndoStim LES Stimulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events
Time Frame: 5 years post-implant
Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up
5 years post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GERD-HRQL
Time Frame: Various timepoints
Change from baseline GERD-HRQL
Various timepoints
Comparison of pH values
Time Frame: Various timepoints
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
Comparison of symptoms and quality of life
Time Frame: Various timepoints
Change from baseline in symptoms (measured by patient diary) and in quality of life (measured by SF-12)
Various timepoints
Change in antisecretory medication use
Time Frame: Various timepoints
Change from baseline in antisecretory medication use
Various timepoints
Change in Structured GI Questionnaire responses (vs. baseline)
Time Frame: Various timepoints
Change from baseline on Structured GI Questionnaire responses
Various timepoints
Change in sleep related quality of life
Time Frame: Various timepoints
Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index)
Various timepoints
Change in work productivity impairment
Time Frame: Various timepoints
Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire)
Various timepoints
Change in Reflux Disease Questionnaire (RDQ) scores
Time Frame: Various timepoints
Change from baseline in RDQ scores
Various timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoStim Inc.

Investigators

  • Study Director: Virender K Sharma, MD, EndoStim Inc.
  • Principal Investigator: Joachim Labenz, MD, Diakonie Klinikum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on GERD

Clinical Trials on EndoStim LES Stimulation System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe