Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease
|Gastroesophageal Reflux Disease||Device: EndoStim LES Stimulation System||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Feasibility Study: An Evaluation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD)|
- Primary Safety Endpoint [ Time Frame: 3 months ]Safety will be assessed by incidence and severity of adverse events through 12-week (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device implant and completion of the Week 12 evaluation: (1) death, or (2) medical morbidity, including myocardial infarction, pneumonia, wound infection, or perforation requiring hospitalization.
- Primary Endpoint: Functionality [ Time Frame: Up to 3 months ]Functionality of the EndoStim system will be assessed by the ability of the device to initiate stimulation as programmed and to accurately detect the patient's posture. Indication of device detection when the patient is lying horizontally and when standing up will be recorded.
- GERD-HRQL [ Time Frame: 3 months ]Improvement in GERD-HRQL with LES stimulation at the 12-weeks (3 months) follow-up compared to baseline
- GERD Symptoms [ Time Frame: 3 months ]Changes in GERD symptoms as measured by the patient daily symptom-diary as well as the impact of GERD symptoms on quality of life as measured by SF-12 will be compared between baseline assessments and post-implant measures at 12 weeks (3 months).
- Lower Esophageal Measures [ Time Frame: 3 months ]The baseline LES end expiratory pressure and the on-stimulation LES end expiratory pressure at 3 months
- Esophageal Acid Exposure [ Time Frame: 3 months ]Total fractional esophageal acid exposure time with pH < 4.0. The data on baseline esophageal acid exposure off-therapy, prior to surgical implant of the stimulator and on-stimulation at 12 weeks (3 months) post-implant
|Study Start Date:||September 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Single Arm open label
EndoStim LES Stimulation System
Device: EndoStim LES Stimulation System
The EndoStim LES Stimulation System comprises three components:
an electrical stimulation lead an implantable pulse generator (IPG) and an external programmer.
EndoStim is developing an investigational medical device specifically designed to deliver electrical stimulation to the LES and has completed two clinical feasibility studies using the EndoStim stimulation system in fifteen subjects.
Acute electrical stimulation resulted in significant LES pressure with no adverse effects reported.
Results of these studies are promising and warrant additional clinical study to evaluate the effectiveness of EndoStim stimulation system to treat GERD over time.
In this study, EndoStim proposes using a fully implantable system. Results of this study are expected to provide confirmation of safety of long-term LES stimulation and may provide long term clinical benefit for GERD patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578642
|INDISA Clínica da Familia|
|Principal Investigator:||Leonardo RODRIGUEZ, M.D||INDISA Clínica da Familia, Santiago, Chile|