EndoStim Patient Registry

Terminated

• Conditions: GERD

• Registration Number: NCT02441400
• Lead Sponsor: EndoStim Inc.

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.

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	5 years post-implant	Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up

Secondary Outcome Measures

Name	Time	Method
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	Change from baseline GERD-HRQL
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	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
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 from baseline in symptoms (measured by patient diary) and in quality of life (measured by SF-12)
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 from baseline in antisecretory medication use
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	Change from baseline on Structured GI Questionnaire responses
Change in sleep related quality of life	Sleep related quality of life will be assessed at baseline, 3-6 months post implant, and then annually until 5 years	Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index)
Change in work productivity impairment	Work productivity will be assessed at baseline, 3-6 months post implant, and then annually until 5 years	Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire)
Change in Reflux Disease Questionnaire (RDQ) scores	RDQ questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years	Change from baseline in RDQ scores

Trial Locations

Locations (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

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

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