Image

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

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

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

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

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.

Study details
    Crohn Disease

NCT05469607

Austin Health

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.