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Recruiting Not applicable NCT05469607

The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

No applicable phase (e.g. observational)
Conditions: Crohn Disease

Sponsor: Austin Health

trial.available_in: БГ
Overview
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.
Who can participate
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
Australia (1)
Austin Health
Melbourne , Victoria
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
08.07.2022
Completion date
01.07.2028
Registry ID
NCT05469607
Source
anzctr
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