NCT05469607招募中不适用
The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Safety and efficacy based on endoscopic recurrence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Safety and efficacy based on endoscopic recurrence
时间窗: 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)
次要结局
- Surgical recurrence(6 and 18 months post-operation)
- Clinical recurrence(6 months and 18 months post-operation)
- Endoscopic recurrence(18 months post-operation)
研究者
Dr Peter De Cruz
Head of Inflammatory Bowel Disease Unit
Austin Health
研究点 (2)
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