Gastroesophageal Reflux Disease Clinical Trial
Official title:
An Investigation 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)
The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).
EndoStim has developed an investigational medical device specifically designed to deliver
electrical stimulation to the LES and has completed two clinical feasibility studies using
an external version of the EndoStim stimulation system in fifteen subjects. In these two
short-term studies, electrical stimulation resulted in significant increases in LES
pressure.
This study will further evaluate the safety of the procedure and its feasibility for use in
this group of patients.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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