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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02441400
Date of registration:	01/05/2015
Prospective Registration:	No
Primary sponsor:	EndoStim Inc.
Public title:	EndoStim Patient Registry RESTORE
Scientific title:	EndoStim Patient Registry-LES Stimulation System for the Treatment of GERD
Date of first enrolment:	May 2013
Target sample size:	350
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02441400
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Argentina	Australia	Austria	Colombia	Denmark	Germany	Mexico	Netherlands
Switzerland	United Kingdom

Contacts

Name:	Virender K Sharma, MD
Address:
Telephone:
Email:
Affiliation:	EndoStim Inc.

Name:	Joachim Labenz, MD
Address:
Telephone:
Email:
Affiliation:	Diakonie Klinikum

Key inclusion & exclusion 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

Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

GERD

Intervention(s)

Device: EndoStim LES Stimulation System

Primary Outcome(s)

Incidence and severity of adverse events [Time Frame: 5 years post-implant]

Secondary Outcome(s)

Change in Structured GI Questionnaire responses (vs. baseline) [Time Frame: Various timepoints]

Change in Reflux Disease Questionnaire (RDQ) scores [Time Frame: Various timepoints]

Change in GERD-HRQL [Time Frame: Various timepoints]

Change in antisecretory medication use [Time Frame: Various timepoints]

Change in sleep related quality of life [Time Frame: Various timepoints]

Change in work productivity impairment [Time Frame: Various timepoints]

Comparison of pH values [Time Frame: Various timepoints]

Comparison of symptoms and quality of life [Time Frame: Various timepoints]

Secondary ID(s)

CS500

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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