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

NARecruitingINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

July 8, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

July 31, 2028

Conditions
Crohn Disease
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).

Trial Locations (1)

3084

RECRUITING

Austin Health, Melbourne

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Florey Institute of Neuroscience and Mental Health

UNKNOWN

collaborator

University of Melbourne

OTHER

collaborator

The Bionics Institute of Australia

OTHER

collaborator

University of Queensland Diamantina Institute

UNKNOWN

lead

Austin Health

OTHER_GOV