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

Austin Health

Status

Enrolling

Conditions

Crohn Disease

Treatments

Device: Vagus Nerve Stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT05469607

HREC/52390/Austin-2019

Details and patient eligibility

About

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.

Enrollment

13 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.