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

• Sponsor: Austin Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05469607
• Collaborator: Florey Institute of Neuroscience and Mental Health (Other), University of Melbourne (Other), Bionics Institute (Other), University of Queensland Diamantina Institute (Other)
• Enrollment: 13
• Location: 1
• Anticipated Duration (Months): 71.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Device: Vagus Nerve Stimulator	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
• Actual Study Start Date: Jul 8, 2022
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Jul 1, 2028

Outcome Measures

Primary Outcome Measures

1. Safety and efficacy based on endoscopic recurrence [6 months post-operation]

   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)

Secondary Outcome Measures

1. Endoscopic recurrence [18 months post-operation]

   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)

2. Clinical recurrence [6 months and 18 months post-operation]

   Defined as recurrence of symptoms consistent with recurrent disease, necessitating new treatment, or Crohn's Disease Activity Index (CDAI) > 150

3. Surgical recurrence [6 and 18 months post-operation]

   Defined as the need for further intestinal surgery due to Crohn's disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Austin Health	Melbourne	Victoria	Australia	3084

Sponsors and Collaborators

• Austin Health
• Florey Institute of Neuroscience and Mental Health
• University of Melbourne
• Bionics Institute
• University of Queensland Diamantina Institute

Investigators

• Principal Investigator: Peter De Cruz, MBBS PhD FRACP, Austin Health, Melbourne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Peter De Cruz, Head of Inflammatory Bowel Disease Unit, Austin Health
• ClinicalTrials.gov Identifier: NCT05469607
• Other Study ID Numbers: HREC/52390/Austin-2019
• First Posted: Jul 22, 2022
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr Peter De Cruz, Head of Inflammatory Bowel Disease Unit, Austin Health: Resectional surgery; Post operative prevention of Crohn's recurrence
• Additional relevant MeSH terms: Crohn Disease

Study Results

No Results Posted as of Jul 22, 2022