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

NCT05469607 | Recruiting DMC

• 1 other identifier: HREC/52390/Austin-2019
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Resectional surgery; Post operative prevention of Crohn's recurrence

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months post-operation

Secondary Outcomes (3)

• Endoscopic recurrence

  18 months post-operation

• Clinical recurrence

  6 months and 18 months post-operation

• Surgical recurrence

  6 and 18 months post-operation

Interventions

Vagus Nerve Stimulator DEVICE

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Austin Health: lead
• Florey Institute of Neuroscience and Mental Health: collaborator
• University of Melbourne: collaborator
• The Bionics Institute of Australia: collaborator
• University of Queensland Diamantina Institute: collaborator

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Peter De Cruz, MBBS PhD FRACP

  Austin Health, Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter De Cruz, MBBS PhD FRACP

CONTACT

+61 3 9496 6233; Peter.DeCruz@austin.org.au

Raquel Pena, B.Pharm, CTC

CONTACT

+61 3 9496 5327; IBDtrials@austin.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Inflammatory Bowel Disease Unit

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 22, 2022
• Study Start: July 8, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)