Back to results

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

Primary Purpose

Crohn Disease

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Vagus Nerve Stimulator

About this trial

This is an interventional prevention trial for Crohn Disease focused on measuring Resectional surgery, Post operative prevention of Crohn's recurrence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Austin HealthRecruiting

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Clinical recurrence

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

Surgical recurrence

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

Full Information

NCT ID

NCT05469607

First Posted

July 7, 2022

Last Updated

February 6, 2023

Sponsor

Austin Health

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05469607

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2022 (Actual)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Austin Health

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

Resectional surgery, Post operative prevention of Crohn's recurrence

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Vagus Nerve Stimulator

Intervention Description

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 Outcome Measure Information:

Title

Safety and efficacy based on endoscopic recurrence

Description

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)

Time Frame

6 months post-operation

Secondary Outcome Measure Information:

Title

Endoscopic recurrence

Description

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)

Time Frame

18 months post-operation

Title

Clinical recurrence

Description

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

Time Frame

6 months and 18 months post-operation

Title

Surgical recurrence

Description

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

Time Frame

6 and 18 months post-operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter De Cruz, MBBS PhD FRACP

Phone

+61 3 9496 6233

Peter.DeCruz@austin.org.au

First Name & Middle Initial & Last Name or Official Title & Degree

Raquel Pena, B.Pharm, CTC

Phone

+61 3 9496 5327

IBDtrials@austin.org.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter De Cruz, MBBS PhD FRACP

Organizational Affiliation

Austin Health, Melbourne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Austin Health

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raquel Pena, B.Pharm, CTC

Phone

+613 9496 5327

IBDtrials@austin.org.au

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs