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RECRUITING
NCT05469607
NA

The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

Sponsor: Austin Health

View on ClinicalTrials.gov

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

DEVICE

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