The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAustin Health
About this trial
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
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vagus Nerve Stimulator
Treatment groups
No treatment groups listed
Sponsors and collaborators
Austin Health
Lead sponsor
Florey Institute of Neuroscience and Mental Health
Collaborator
University of Melbourne
Collaborator
The Bionics Institute of Australia
Collaborator
University of Queensland Diamantina Institute
Collaborator
Source ClinicalTrials.gov