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

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn Disease

Intervention / Treatment
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* Device: Vagus Nerve Stimulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vagus Nerve Stimulator|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy based on endoscopic recurrence | Recurrence defined as the presence of any aphthous ulcers, and severe recurrence defined as an endoscopic Rutgeerts score ≥ 2 (5 aphthous ulcers or larger ulcers confined to the anastomosis) | 6 months post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic recurrence | Recurrence defined as the presence of any aphthous ulcers, and severe recurrence defined as an endoscopic Rutgeerts score ≥ 2 (5 aphthous ulcers or larger ulcers confined to the anastomosis) | 18 months post-operation | 
| Clinical recurrence | Defined as recurrence of symptoms consistent with recurrent disease, necessitating new treatment, or Crohn's Disease Activity Index (CDAI) > 150 | 6 months and 18 months post-operation | 
| Surgical recurrence | Defined as the need for further intestinal surgery due to Crohn's disease | 6 and 18 months post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resectional surgery, Post operative prevention of Crohn's recurrence