158
Participants
Start Date
February 29, 2016
Primary Completion Date
February 15, 2018
Study Completion Date
July 4, 2019
E-Motion System
"E-Motion Tube: A disposable oro/nasogastric feeding tube fitted with stainless steel electrodes along its length that delivers the stimulation to the esophageal mucosa.~E-motion EPG 1000: a durable, touchscreen operated, bedside control unit that generates the electric stimulation pattern and sends it via the feeding tube to the esophagus.~By applying predetermined sequences of electrical stimulation to various locations along the esophagus asynchronous esophageal motion is induced, resulting is reduction of reflux and increased GI motility, enabling safer and better feeding."
Sham E-Motion System
The sham EPG will resemble the investigational EPG. The external shape, interface, lights, and switches will be exactly the same. The Sham device will emit a low intensity pulsation so that, it will not unblind the patient nor health care professional. In the event that unblinding does occur, we will take steps to mask the identity of the EPG by covering the number of the device with tape to prevent members of the clinical team becoming aware of which device is active or sham.
Royal Alexandria Hospital, Edmonton
St. Boniface Hospital, Winnipeg
Queen Elizabeth II Health Sciences Centre, Halifax
Ottawa OHRI, Ottawa
Sunnybrook Health Sciences Centre, Toronto
Hopital Maisonneuve-Rosemont, Montreal
Hopital Sacre-Coeur, Montreal
London Health Sciences, London
Montreal General Hospital, Montreal
Hoptial L'ENfant Jesus, Québec
University of Sherbrooke Fleurimont, Sherbrooke
Lead Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
OTHER
E-Motion Medical Ltd.
INDUSTRY