Trial Review

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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
Scientific title
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Secondary ID [1] 0 0
HREC/52390/Austin-2019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and efficacy based on endoscopic recurrence
Timepoint [1] 0 0
6 months post-operation
Secondary outcome [1] 0 0
Endoscopic recurrence
Timepoint [1] 0 0
18 months post-operation
Secondary outcome [2] 0 0
Clinical recurrence
Timepoint [2] 0 0
6 months and 18 months post-operation
Secondary outcome [3] 0 0
Surgical recurrence
Timepoint [3] 0 0
6 and 18 months post-operation

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).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Florey Institute of Neuroscience and Mental Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Bionics Institute
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Queensland Diamantina Institute
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05469607
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter De Cruz, MBBS PhD FRACP
Address 0 0
Austin Health, Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter De Cruz, MBBS PhD FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 3 9496 6233
Fax 0 0
Email 0 0
Peter.DeCruz@austin.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05469607