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

Not Applicable

Recruiting

• Conditions: Crohn Disease

• Registration Number: NCT05469607
• Lead Sponsor: Austin Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study Start: 2022-07-08
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2026-12
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Austin Health; 🇦🇺 Melbourne, Victoria, Australia