The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAustin Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Vagus Nerve Stimulator
DeviceThe 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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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)
Time frame
6 months post-operationSecondary outcomes
1
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)
Time frame
18 months post-operation2
Clinical recurrence
Defined as recurrence of symptoms consistent with recurrent disease, necessitating new treatment, or Crohn's Disease Activity Index (CDAI) \> 150
Time frame
6 months and 18 months post-operation3
Surgical recurrence
Defined as the need for further intestinal surgery due to Crohn's disease
Time frame
6 and 18 months post-operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Austin Health
Lead sponsor
Florey Institute of Neuroscience and Mental Health
Collaborator
University of Melbourne
Collaborator
The Bionics Institute of Australia
Collaborator
University of Queensland Diamantina Institute
Collaborator
Source ClinicalTrials.gov