Crohn'sRecruiting
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Not applicable · Testing Vagus Nerve Stimulator · 1 site · Austin Health
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Vagus Nerve Stimulator (a device) to see if it can prevent disease or complications. Condition(s) listed: Crohn Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- All patients aged 18 years or older with Crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in macroscopic normality.
- Patients having a reversal of a temporary ileostomy created after previous surgery for Crohn's disease may be enrolled provided that the reversal of the ileostomy results in a primary anastomosis and macroscopic normality of the remaining…
- Patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the intestine.
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 13 participants are expected to take part.
- Start date: 2022-07-08.
- Main results expected around 2026-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Australia.
Main thing being measured
- Safety and efficacy based on endoscopic recurrence (6 months post-operation)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Austin Health |
| Collaborators | The Florey Institute of Neuroscience and Mental Health; University of Melbourne; The Bionics Institute of Australia; University of Queensland Diamantina Institute |
| Enrollment | 13 (estimated) |
| Start date | 2022-07-08 |
| Primary completion (est.) | 2026-12 |
| First posted | 2022-07-22 |
| Last updated | 2023-02-08 |
| Official title | The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD |
| ClinicalTrials.gov ID | NCT05469607 |
Interventions
- Vagus Nerve Stimulator (Device)
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 respo…
Full eligibility criteria (from the record)
Inclusion Criteria: * All patients aged 18 years or older with Crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in macroscopic normality. * Patients having a reversal of a temporary ileostomy created after previous surgery for Crohn's disease may be enrolled provided that the reversal of the ileostomy results in a primary anastomosis and macroscopic normality of the remaining bowel. * Patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the intestine. * Patients must have proven history of Crohn's disease based on (clinical, radiologic, endoscopic and histologic criteria). Exclusion Criteria: * Patients with anastomosis which is endoscopically inaccessible by standard colonoscopy. * Patients in whom there is persisting macroscopic abnormality post-surgical resection. * Patients with Crohn's disease who have an end stoma (ileostomy or colostomy). * Patients for whom endoscopy is not suitable due to co-morbidities or unwell clinical state * Inability to give informed consent. * Inability to obtain access to the anastomosis at colonoscopy. * Suspected perforation of the gastrointestinal tract. * Patients who are pregnant or breastfeeding.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health | Melbourne, Victoria | Australia | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.