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

A

Austin Health

Status

Enrolling

Conditions

Crohn Disease

Treatments

Device: Vagus Nerve Stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT05469607
HREC/52390/Austin-2019

Details and patient eligibility

About

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.

Enrollment

13 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Raquel Pena, B.Pharm, CTC; Peter De Cruz, MBBS PhD FRACP

Data sourced from clinicaltrials.gov

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