The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

NCT ID: NCT05469607

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2028-07-31

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

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 Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florey Institute of Neuroscience and Mental Health

UNKNOWN

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

The Bionics Institute of Australia

OTHER

Sponsor Role: collaborator

University of Queensland Diamantina Institute

UNKNOWN

Sponsor Role: collaborator

Austin Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Peter De Cruz

Head of Inflammatory Bowel Disease Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter De Cruz, MBBS PhD FRACP

Role: PRINCIPAL_INVESTIGATOR

Austin Health, Melbourne

Locations

Austin Health

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Peter De Cruz, MBBS PhD FRACP

Role: CONTACT

Peter.DeCruz@austin.org.au

+61 3 9496 6233

Raquel Pena, B.Pharm, CTC

Role: CONTACT

IBDtrials@austin.org.au

+61 3 9496 5327

Facility Contacts

Raquel Pena, B.Pharm, CTC

Role: primary

IBDtrials@austin.org.au

+613 9496 5327

Other Identifiers

HREC/52390/Austin-2019

Identifier Type: -

Identifier Source: org_study_id