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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05469607
Registration number
NCT05469607
Ethics application status
Date submitted
7/07/2022
Date registered
22/07/2022
Date last updated
8/02/2023
Titles & IDs
Public title
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
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Scientific title
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
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Secondary ID [1]
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HREC/52390/Austin-2019
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Vagus Nerve Stimulator
Treatment: Devices: Vagus Nerve Stimulator
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).
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and efficacy based on endoscopic recurrence
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Assessment method [1]
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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)
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Timepoint [1]
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6 months post-operation
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Secondary outcome [1]
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Endoscopic recurrence
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Assessment method [1]
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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)
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Timepoint [1]
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18 months post-operation
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Secondary outcome [2]
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Clinical recurrence
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Assessment method [2]
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Defined as recurrence of symptoms consistent with recurrent disease, necessitating new treatment, or Crohn's Disease Activity Index (CDAI) > 150
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Timepoint [2]
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6 months and 18 months post-operation
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Secondary outcome [3]
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Surgical recurrence
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Assessment method [3]
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Defined as the need for further intestinal surgery due to Crohn's disease
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Timepoint [3]
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6 and 18 months post-operation
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2028
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Actual
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Sample size
Target
13
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Austin Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Florey Institute of Neuroscience and Mental Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Melbourne
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Bionics Institute
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Queensland Diamantina Institute
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05469607
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peter De Cruz, MBBS PhD FRACP
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Address
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Austin Health, Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Peter De Cruz, MBBS PhD FRACP
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Address
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Country
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Phone
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+61 3 9496 6233
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05469607
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