AzTrials
AzTrials

GERDRESTORENCT02441400

EndoStim Patient Registry

An observational study of GERD, run by EndoStim Inc. at 30 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
GERD
What is being tested?
EndoStim LES Stimulation System
Type of treatment
Medical device
How many people
350 participants
Where
30 sitesin 7 countries
Study dates
May 2013to 12 Jul 2022
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects with a diagnosis of GERD who are undergoing or have already undergone EndoStim LES stimulation system implantation.

Who may be able to join

  • 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)

Who cannot join

  • 1. Subject meets therapy contraindications

Trial locations and contacts

30 sites in 7 countries.

30 sites in 7 countries

Germany23 sites

  • SANA Klinikum Lichtenberg

    Berlin

  • Evangelisches Krankenhaus Castrop-Rauxel

    Castrop-Rauxel

  • Heilig Geist-Krankenhaus Köln

    Cologne

  • St. Marienstift Krankenhaus Friesoythe

    Friesoythe

  • Hospital zum Heiligen Geist Fritzlar

    Fritzlar

  • Klinikum Garmisch-Partenkirchen

    Garmisch-Partenkirchen

  • Wolfartklinik Graefelfing

    Gräfelfing

  • Martha Maria Krankenhaus Halle-Dölau

    Halle

  • Asklepios Klinik Altona

    Hamburg

  • KRH Klinikum Siloah Hannover Oststadt

    Hanover

  • Evangelisches Krankenhaus Herne

    Herne

  • Klinikum Konstanz

    Konstanz

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universitätsmedizin Mannheim

    Mannheim

  • Klinikum Memmingen

    Memmingen

  • Klinikum Minden Johannes Wesling

    Minden

  • Klinikum Muenchen Bogenhausen

    München

  • Friedrich-Ebert-Krankenhaus Neumünster

    Neumünster

  • Asklepios Schwalm-Eder Kliniken GmbH

    Schwalmstadt

  • Jung Stilling - Siegen

    Siegen

  • St. Marien-Krankenhaus Siegen

    Siegen

  • Klinikum Stuttgart, Krankenhaus Bad Cannstatt

    Stuttgart

  • Ev. Krankenhaus Wesel GmbH

    Wesel

Other trials in Germany

United Kingdom2 sites

  • Spire Leicester Hospital

    Leicester

  • University Hospital Southampton

    Southampton

Other trials in United Kingdom

Argentina1 site

  • Fundacion Favaloro

    Buenos Aires

Other trials in Argentina

Austria1 site

  • University Hospital Vienna

    Vienna

Other trials in Austria

Denmark1 site

  • Aarhus University Hospital

    Aarhus

Other trials in Denmark

Mexico1 site

  • Hospital San José

    Monterrey

Other trials in Mexico

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions
GERD
Being tested
EndoStim LES Stimulation System
Keywords
GERD, LES Pressure, Electrical Stimulation
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoStim LES Stimulation SystemDevice

Study groups in NCT02441400
Study groupRoleWhat they receive
EndoStim LES Stimulation System implant.Registry subjects whom have been implanted commercially with the EndoStim LES Stimulation System device.
Receives: Device: EndoStim LES Stimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events

    Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up

    Measured: 5 years post-implant

Secondary outcomes (8)

  1. Change in GERD-HRQL

    Change from baseline GERD-HRQL

    Measured: Change in GERD-HRQL questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years

  2. 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

    Measured: 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

  3. 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)

    Measured: Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years

  4. Change in antisecretory medication use

    Change from baseline in antisecretory medication use

    Measured: The use of antisecretory medication will be assessed at baseline, 3-6 months post implant, and then annually until 5 years

  5. Change in Structured GI Questionnaire responses (vs. baseline)

    Change from baseline on Structured GI Questionnaire responses

    Measured: Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years

  6. Change in sleep related quality of life

    Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index)

    Measured: Sleep related quality of life will be assessed at baseline, 3-6 months post implant, and then annually until 5 years

  7. Change in work productivity impairment

    Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire)

    Measured: Work productivity will be assessed at baseline, 3-6 months post implant, and then annually until 5 years

  8. Change in Reflux Disease Questionnaire (RDQ) scores

    Change from baseline in RDQ scores

    Measured: RDQ questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startMay 2013
  3. Primary completion12 Jul 2022
  4. Study completion12 Jul 2022

Why it stopped: Company no longer operational

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
350 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441400
Sponsor's protocol ID
CS500
Acronym
RESTORE
Status last verified
May 2026
First submitted
1 May 2015
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22292889

  • 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.

    PubMed 23073680

Questions about this trial

What is this clinical trial studying?

An observational study of GERD, run by EndoStim Inc. at 30 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Germany, United Kingdom, Argentina, Austria, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Company no longer operational). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (time frame: 5 years post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441400, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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