RecruitingRecruiting
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
NCT05469607 · Austin Health
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 13 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-07-08
Estimated completion: 2028-07
Last updated: 2023-02-08
Interventions
Device: Vagus Nerve Stimulator
Primary outcomes
- • Safety and efficacy based on endoscopic recurrence (6 months post-operation)
Sponsor
Austin Health · other_gov
With: The Florey Institute of Neuroscience and Mental Health, University of Melbourne, The Bionics Institute of Australia, University of Queensland Diamantina Institute
Contacts & investigators
ContactPeter De Cruz, MBBS PhD FRACP · contact · Peter.DeCruz@austin.org.au · +61 3 9496 6233
ContactRaquel Pena, B.Pharm, CTC · contact · IBDtrials@austin.org.au · +61 3 9496 5327
InvestigatorPeter De Cruz, MBBS PhD FRACP · principal_investigator, Austin Health, Melbourne
All locations (1)
Austin HealthRecruiting
Melbourne, Victoria, Australia