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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469607
• Other study ID #: HREC/52390/Austin-2019
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: July 2028

Study information

• Verified date: February 2023
• Source: Austin Health
• Contact: Peter De Cruz, MBBS PhD FRACP
• Phone: +61 3 9496 6233
• Email: Peter.DeCruz[@]austin.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: July 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
Austin Health	Bionics Institute, Florey Institute of Neuroscience and Mental Health, University of Melbourne, University of Queensland Diamantina Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Surgical recurrence	Defined as the need for further intestinal surgery due to Crohn's disease	6 and 18 months post-operation