The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Austin Health
13 participants
Jul 8, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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.
Interventions
The device consists of implantable (inside the body) and external (outside the body) components. Implantable components consist of a stimulating/recording electrode assembly that is placed around the vagus nerve in the abdomen, between the diaphragm and the stomach, a cable connecting the electrode assembly to an implantable pulse generator (IPG) that generates the stimulus and records nerve responses. The external components include a Clinical Control/Review Tool (used by the study team after implantation to adjust and periodically review the stimulation settings) and a Patient Control Unit and Charger (to turn on/off the system and perform limited adjustment of the stimulation strategy).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05469607