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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Australia
Austin Health
RECRUITING
Melbourne
Contact Information
Primary
Peter De Cruz, MBBS PhD FRACP
Peter.DeCruz@austin.org.au
+61 3 9496 6233
Backup
Raquel Pena, B.Pharm, CTC
IBDtrials@austin.org.au
+61 3 9496 5327
Time Frame
Start Date: 2022-07-08
Estimated Completion Date: 2028-07
Participants
Target number of participants: 13
Related Therapeutic Areas
Sponsors
Collaborators: Florey Institute of Neuroscience and Mental Health, University of Queensland Diamantina Institute, The Bionics Institute of Australia, University of Melbourne
Leads: Austin Health

This content was sourced from clinicaltrials.gov