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New treatment option for Crohn Disease
Official title The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
ClinicalTrials.gov ID: NCT05469607
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- All patients aged 18 years or older with Crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in...
- Patients having a reversal of a temporary ileostomy created after previous surgery for Crohn's disease may be enrolled provided that the reversal of...
- Patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the...
- Patients must have proven history of Crohn's disease based on (clinical, radiologic, endoscopic and histologic criteria).
You likely can't join if
- 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.
See the full eligibility 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...
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.