GERD
Conditions
Keywords
GERD, LES Pressure, Electrical Stimulation
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.
Interventions
Sponsors
EndoStim Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Argentina, Austria, Denmark, Germany, Mexico, Netherlands, United Kingdom
Contacts
STUDY_DIRECTORVirender K Sharma, MD
EndoStim Inc.
PRINCIPAL_INVESTIGATORJoachim Labenz, MD
Diakonie Klinikum
Outcome results
None listed