Crohn DiseaseNCT05469607
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
A study testing Vagus Nerve Stimulator in people with Crohn Disease, run by Austin Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Vagus Nerve Stimulator
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jul 2022to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Austin Health
Melbourne, Victoria, 3084
Raquel Pena, B.Pharm, CTC, +613 9496 5327, IBDtrials@austin.org.au
About this study
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.
- Conditions
- Crohn Disease
- Being tested
- Vagus Nerve Stimulator
- Keywords
- Resectional surgery, Post operative prevention of Crohn's recurrence
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve StimulatorDevice
The device consists of implantable (inside the body) and external (outside the body) components. Implantable components consist of a stimulating/recording electrode assembly that is placed around the vagus nerve in the abdomen, between the diaphragm and the stomach, a cable connecting the electrode assembly to an implantable pulse generator (IPG) that generates the stimulus and records nerve responses. The external components include a Clinical Control/Review Tool (used by the study team after implantation to adjust and periodically review the stimulation settings) and a Patient Control Unit and Charger (to turn on/off the system and perform limited adjustment of the stimulation strategy).
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy based on endoscopic recurrence
Recurrence defined as the presence of any aphthous ulcers, and severe recurrence defined as an endoscopic Rutgeerts score ≥ 2 (5 aphthous ulcers or larger ulcers confined to the anastomosis)
Measured: 6 months post-operation
Secondary outcomes (3)
Endoscopic recurrence
Recurrence defined as the presence of any aphthous ulcers, and severe recurrence defined as an endoscopic Rutgeerts score ≥ 2 (5 aphthous ulcers or larger ulcers confined to the anastomosis)
Measured: 18 months post-operation
Clinical recurrence
Defined as recurrence of symptoms consistent with recurrent disease, necessitating new treatment, or Crohn's Disease Activity Index (CDAI) > 150
Measured: 6 months and 18 months post-operation
Surgical recurrence
Defined as the need for further intestinal surgery due to Crohn's disease
Measured: 6 and 18 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start8 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Collaborators
- The Florey Institute of Neuroscience and Mental Health, University of Melbourne, The Bionics Institute of Australia, University of Queensland Diamantina Institute
- Responsible party
- Principal investigator, Dr Peter De Cruz, Austin Health
- Investigators
- Peter De Cruz, MBBS PhD FRACP, Principal investigator, Austin Health, Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469607
- Sponsor's protocol ID
- HREC/52390/Austin-2019
- Status last verified
- Feb 2023
- First submitted
- 7 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
- ClinicalTrials.gov ID
- NCT05469607
- Acronym / sponsor ID
- HREC/52390/Austin-2019
- Conditions
- Crohn Disease
- Keywords
- Resectional surgery, Post operative prevention of Crohn's recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Austin HealthOther government
- Collaborators
- The Florey Institute of Neuroscience and Mental Health, University of Melbourne, The Bionics Institute of Australia, University of Queensland Diamantina Institute
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve StimulatorThe device consists of implantable (inside the body) and external (outside the body) components. Implantable components consist of a stimulating/recording electrode assembly that is placed around the vagus nerve in the abdomen, between the diaphragm and the stomach, a cable connecting the electrode assembly to an implantable pulse generator (IPG) that generates the stimulus and records nerve responses. The external components include a Clinical Control/Review Tool (used by the study team after implantation to adjust and periodically review the stimulation settings) and a Patient Control Unit and Charger (to turn on/off the system and perform limited adjustment of the stimulation strategy). | Device | – |
Primary outcome
Safety and efficacy based on endoscopic recurrence
Time frame: 6 months post-operation
Recurrence defined as the presence of any aphthous ulcers, and severe recurrence defined as an endoscopic Rutgeerts score ≥ 2 (5 aphthous ulcers or larger ulcers confined to the anastomosis)
3 secondary outcomes
Endoscopic recurrence
Time frame: 18 months post-operation
Clinical recurrence
Time frame: 6 months and 18 months post-operation
Surgical recurrence
Time frame: 6 and 18 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter De Cruz, MBBS PhD FRACP principal investigator
Austin Health, Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulator in people with Crohn Disease, run by Austin Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter De Cruz, MBBS PhD FRACP (+61 3 9496 6233, Peter.DeCruz@austin.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy based on endoscopic recurrence (time frame: 6 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.