The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
About This Trial
The purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Vagus Nerve Stimulator
The device consists of implantable (inside the body) and external (outside the body) components. Implantable components consist of a stimulating/recording electrode assembly that is placed around the vagus nerve in the abdomen, between the diaphragm and the stomach, a cable connecting the electrode assembly to an implantable pulse generator (IPG) that generates the stimulus and records nerve responses. The external components include a Clinical Control/Review Tool (used by the study team after implantation to adjust and periodically review the stimulation settings) and a Patient Control Unit and Charger (to turn on/off the system and perform limited adjustment of the stimulation strategy).