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

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 Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Device: Vagus Nerve Stimulator

• Study Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter De Cruz, MBBS PhD FRACP; Phone Number: +61 3 9496 6233; Email: Peter.DeCruz@austin.org.au
• Study Contact Backup: Name: Raquel Pena, B.Pharm, CTC; Phone Number: +61 3 9496 5327; Email: IBDtrials@austin.org.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
      • Contact: Raquel Pena, B.Pharm, CTC; Phone Number: +613 9496 5327; Email: IBDtrials@austin.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	6 months and 18 months post-operation
Surgical recurrence	Defined as the need for further intestinal surgery due to Crohn's disease	6 and 18 months post-operation

Collaborators and Investigators

• Sponsor: Austin Health
• Collaborators: University of Melbourne; Bionics Institute; Florey Institute of Neuroscience and Mental Health; University of Queensland Diamantina Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2022
• Primary Completion (ANTICIPATED): December 1, 2026
• Study Completion (ANTICIPATED): July 1, 2028

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (ACTUAL): July 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Resectional surgery; Post operative prevention of Crohn's recurrence
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: HREC/52390/Austin-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No