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Clinical Trial

An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux

NCT: NCT02749071 · TERMINATED

NCT IDNCT02749071
StatusTERMINATED
SponsorEndoStim Inc. (INDUSTRY)
First posted
Last updated

Brief Summary

The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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