NCT05469607 The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
| NCT ID | NCT05469607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Austin Health |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 13 participants |
| Start Date | 2022-07-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 13 participants in total. It began in 2022-07-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Peter De Cruz, MBBS PhD FRACP
PRINCIPAL INVESTIGATOR
Austin Health, Melbourne
Frequently Asked Questions
Who can join the NCT05469607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05469607 currently recruiting?
Yes, NCT05469607 is actively recruiting participants. Contact the research team at Peter.DeCruz@austin.org.au for enrollment information.
Where is the NCT05469607 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT05469607 clinical trial?
NCT05469607 is sponsored by Austin Health. The principal investigator is Peter De Cruz, MBBS PhD FRACP at Austin Health, Melbourne. The trial plans to enroll 13 participants.