Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05469607

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

Led by Austin Health · Updated on 2023-02-08

13

Participants Needed

1

Research Sites

312 weeks

Total Duration

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Sponsors

A

Austin Health

Lead Sponsor

F

Florey Institute of Neuroscience and Mental Health

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older with Crohn's disease who have undergone resection resulting in a primary anastomosis with normal appearance
  • Patients having reversal of a temporary ileostomy after previous Crohn's disease surgery, resulting in a primary anastomosis and normal bowel
  • Patients with co-existing perianal disease if resection led to a primary anastomosis and normal intestine
  • Proven history of Crohn's disease based on clinical, radiologic, endoscopic, and histologic criteria
Not Eligible

You will not qualify if you...

  • Patients with anastomosis not accessible by standard colonoscopy
  • Patients with ongoing macroscopic abnormalities after surgery
  • Patients with Crohn's disease who have an end stoma (ileostomy or colostomy)
  • Patients unsuitable for endoscopy due to other illnesses or poor health
  • Patients unable to give informed consent
  • Patients for whom colonoscopy access to the anastomosis is not possible
  • Suspected gastrointestinal tract perforation
  • Pregnant or breastfeeding patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Austin Health

Melbourne, Victoria, Australia, 3084

Actively Recruiting

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Research Team

P

Peter De Cruz, MBBS PhD FRACP

CONTACT

R

Raquel Pena, B.Pharm, CTC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

0

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