Trials / Completed
CompletedNCT01578642
Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- EndoStim Inc. · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The EndoStim Stimulation System is an investigational device intended to improve the lower esophageal sphincter (LES) resting tone and restore LES function in individuals suffering with gastroesophageal reflux disease (GERD).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2012-04-17
- Last updated
- 2014-02-12
Locations
1 site across 1 country: Chile
Source: ClinicalTrials.gov record NCT01578642. Inclusion in this directory is not an endorsement.