Not provided
Not provided
Not provided
Not provided
Not provided
Company no longer operational
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoStim LES Stimulation System implant. | Registry subjects whom have been implanted commercially with the EndoStim LES Stimulation System device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoStim LES Stimulation System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up | 5 years post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GERD-HRQL | Change from baseline GERD-HRQL | Change in GERD-HRQL questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years |
| Comparison of pH values |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Subject meets therapy contraindications
Not provided
Not provided
Not provided
Subjects with a diagnosis of GERD who are undergoing or have already undergone EndoStim LES stimulation system implantation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Virender K Sharma, MD | EndoStim Inc. | Study Director |
| Joachim Labenz, MD | Diakonie Klinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Favaloro | Buenos Aires | Argentina | ||||
| University Hospital Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22292889 | Background | 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. | |
| 23073680 |
| Label | URL |
|---|---|
| Registry sponsor's website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
| 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 |
| 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) | Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years |
| Change in antisecretory medication use | Change from baseline 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 in Structured GI Questionnaire responses (vs. baseline) | Change from baseline on Structured GI Questionnaire responses | Symptoms will be assessed at baseline, 3-6 months post implant, and then annually until 5 years |
| Change in sleep related quality of life | Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index) | Sleep related quality of life will be assessed at baseline, 3-6 months post implant, and then annually until 5 years |
| Change in work productivity impairment | Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire) | Work productivity will be assessed at baseline, 3-6 months post implant, and then annually until 5 years |
| Change in Reflux Disease Questionnaire (RDQ) scores | Change from baseline in RDQ scores | RDQ questionnaire score will be assessed at baseline, 3-6 months post implant, and then annually until 5 years |
| Vienna |
| Austria |
| Aarhus University Hospital | Aarhus | Denmark |
| SANA Klinikum Lichtenberg | Berlin | Germany |
| Evangelisches Krankenhaus Castrop-Rauxel | Castrop-Rauxel | Germany |
| Heilig Geist-Krankenhaus Köln | Cologne | 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 |
| Asklepios Klinik Altona | Hamburg | Germany |
| KRH Klinikum Siloah Hannover Oststadt | Hanover | Germany |
| Evangelisches Krankenhaus Herne | Herne | Germany |
| Klinikum Konstanz | Konstanz | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | Germany |
| Universitätsmedizin Mannheim | Mannheim | Germany |
| Klinikum Memmingen | Memmingen | Germany |
| Klinikum Minden Johannes Wesling | Minden | Germany |
| Klinikum Muenchen Bogenhausen | München | Germany |
| Friedrich-Ebert-Krankenhaus Neumünster | Neumünster | Germany |
| Asklepios Schwalm-Eder Kliniken GmbH | Schwalmstadt | Germany |
| Jung Stilling - Siegen | Siegen | Germany |
| St. Marien-Krankenhaus Siegen | Siegen | Germany |
| Klinikum Stuttgart, Krankenhaus Bad Cannstatt | Stuttgart | Germany |
| Ev. Krankenhaus Wesel GmbH | Wesel | Germany |
| Hospital San José | Monterrey | Mexico |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Spire Leicester Hospital | Leicester | United Kingdom |
| University Hospital Southampton | Southampton | United Kingdom |
| 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. |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided