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

NCT05469607 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-02-08

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Florey Institute of Neuroscience and Mental Health

    collaborator UNKNOWN

  • University of Melbourne

    collaborator OTHER

  • The Bionics Institute of Australia

    collaborator OTHER

  • University of Queensland Diamantina Institute

    collaborator UNKNOWN

  • Austin Health

    lead OTHER_GOV

Principal Investigators

  • Peter De Cruz, MBBS PhD FRACP · Austin Health, Melbourne

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2026-12-31
Completion
2028-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469607 on ClinicalTrials.gov