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NCT Number: NCT05469607

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Austin Health

Melbourne, Victoria, 3084, Australia

Location status: Recruiting

Location contact

Raquel Pena, B.Pharm, CTC

CONTACT

[email protected]

+613 9496 5327

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Safety and efficacy based on endoscopic recurrence

    Time frame: 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 outcomes

  1. Endoscopic recurrence

    Time frame: 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

    Time frame: 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

    Time frame: 6 and 18 months post-operation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Peter De Cruz, MBBS PhD FRACP

CONTACT

[email protected]

+61 3 9496 6233

Raquel Pena, B.Pharm, CTC

CONTACT

[email protected]

+61 3 9496 5327

Sponsors and collaborators

Lead sponsor

Austin Health

Other Gov

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Jul 22, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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