The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Recruiting now · Not applicable
Conditions studied: Crohn Disease
In brief
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.
Key facts
- Study ID
- NCT05469607
- Run by
- Austin Health
- People needed
- 13
- Starts
- 2022-07-08
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2023-02-08
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Austin Health — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.