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The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Sponsor: Austin Health
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2022-07-08
Completion Date
2028-07
Last Updated
2023-02-08
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (1)
Austin Health
Melbourne, Victoria, Australia