Using neurotechnology to treat Crohn's disease after surgery
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
NA · Austin Health · NCT05469607
This study is testing if a device that stimulates the vagus nerve can help prevent Crohn's disease from coming back in patients who have just had surgery for it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Austin Health (other gov) |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT05469607 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of vagal nerve neuromodulation in patients who have undergone surgical resection for Crohn's disease. It is a prospective, single-center cohort study that aims to assess the effectiveness of a vagus nerve stimulator in preventing the recurrence of Crohn's disease post-operatively. Participants will be monitored for safety and outcomes related to their condition following the intervention. The study focuses on patients with macroscopic normality after surgery, ensuring a targeted approach to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with a confirmed history of Crohn's disease who have undergone resection surgery resulting in macroscopic normality.
Not a fit: Patients with ongoing macroscopic abnormalities post-surgery or those with end stomas will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of Crohn's disease in patients after surgical intervention.
How similar studies have performed: While the use of neuromodulation in gastrointestinal conditions is emerging, this specific approach for Crohn's disease is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Melbourne, Victoria
- Austin Health — Melbourne, Victoria, Australia (RECRUITING)
Study contacts
- Principal investigator: Peter De Cruz, MBBS PhD FRACP — Austin Health, Melbourne
- Study coordinator: Peter De Cruz, MBBS PhD FRACP
- Email: Peter.DeCruz@austin.org.au
- Phone: +61 3 9496 6233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, Resectional surgery, Post operative prevention of Crohn's recurrence