NCT05469607 The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
| NCT ID | NCT05469607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Austin Health |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 13 participants |
| Start Date | 2022-07-08 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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 colost