EndoStim CS-100 FDA study
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Gastroesophageal Reflux Disease (GERD)
IRAS ID
211177
Contact name
Laurence Lovat
Contact email
Sponsor organisation
EndoStim
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 30 days
Research summary
This study is intended to demonstrate the safety and effectiveness of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System in the treatment of subjects with gastroesophageal reflux disease (GERD).
Gastro-oesophageal reflux disease results from acid reflux or chronic heartburn and often requires lifelong treatment. Patients experience backflow of gastric contents from the stomach into the oesophagus, causing symptoms such as heartburn and regurgitation. Many patients also experience disrupted sleep due to symptoms, despite taking medications. Patients with severe symptoms are generally prescribed long-term daily medication.
Chronic oesophageal reflux may lead to serious damage. Possible complications include oesophageal inflammation, ulcers or bleeding, or the development of asthma. Untreated oesophageal inflammation can lead to a pre-cancerous condition called Barrett’s oesophagus.
We are looking for subjects diagnosed with pathological GERD as defined by acidic pH and who continue to have chronic GERD symptoms despite maximum medical therapy. It is designed as a multicentre, randomized, double-blind, sham-controlled study.
EndoStim therapy is a minimally-invasive treatment option for GERD patients suffering from severe symptoms. EndoStim therapy uses low energy electrical stimulation to restore the function of the lower oesophageal sphincter (LES). A healthy LES typically prevents reflux symptoms without affecting normal oesophageal functions such as swallowing or belching. Most GERD patients who have been treated with EndoStim therapy experience significantly reduced reflux symptoms such as heartburn and regurgitation, without the need to continue daily GERD medication.
The EndoStim device consists of a stimulator, similar to a pacemaker, and two electrodes connected to an implantable lead. Through a simple laparoscopic or “keyhole” procedure, the EndoStim electrodes are placed on the lower oesophageal sphincter, and the EndoStim stimulator is placed in the abdomen. The stimulator automatically delivers therapy to the electrodes throughout each day, but patients typically cannot feel the stimulation.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0439
Date of REC Opinion
16 Nov 2016
REC opinion
Further Information Favourable Opinion