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| Name | Class |
|---|---|
| The Florey Institute of Neuroscience and Mental Health | OTHER |
| University of Melbourne | OTHER |
| The Bionics Institute of Australia | OTHER |
| University of Queensland Diamantina Institute |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter De Cruz, MBBS PhD FRACP | Contact | +61 3 9496 6233 | Peter.DeCruz@austin.org.au | |
| Raquel Pena, B.Pharm, CTC | Contact | +61 3 9496 5327 | IBDtrials@austin.org.au |
| Name | Affiliation | Role |
|---|---|---|
| Peter De Cruz, MBBS PhD FRACP | Austin Health, Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Health | Recruiting | Melbourne | Victoria | 3084 | Australia |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| UNKNOWN |
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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 |
| Surgical recurrence | Defined as the need for further intestinal surgery due to Crohn's disease | 6 and 18 months post-operation |
| D007410 | Intestinal Diseases |