NCT05469607Recruiting
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Source: ClinicalTrials.gov · Last updated 8 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 7 Jul 2022
- Start date
- 8 Jul 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Austin Health
- Diseases
- Crohn's disease
- NCT number
- NCT05469607
What you commit to
- Study type: Interventional
- Planned participants: 13
- From 8 Jul 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients in whom there is persisting macroscopic abnormality post-surgical resection.
Other illness
- Patients with Crohn's disease who have an end stoma (ileostomy or colostomy).
- Suspected perforation of the gastrointestinal tract.
Other
- Patients with anastomosis which is endoscopically inaccessible by standard colonoscopy.
- 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.
- Patients who are pregnant or breastfeeding.
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.