Trials / Recruiting
RecruitingNCT05469607
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- Sponsor
- Austin Health · Other Government
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2022-07-08
- Primary completion
- 2026-12-01
- Completion
- 2028-07-01
- First posted
- 2022-07-22
- Last updated
- 2023-02-08
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT05469607. Inclusion in this directory is not an endorsement.