NCT00610207终止不适用
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Fistula Closure (Patient Based)
研究概览
简要总结
Healing anal fistulas in Crohn's patients with an anal fistula plug.
详细描述
The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is diagnosed with Crohn's Disease
- •Patient has a chronically draining anal fistula of Crohn's origin
- •Patient is 18 years old or older
- •Patient has signed an informed consent
排除标准
- •Patient is pregnant or lactating
- •Patient has peri-anal drainage with originates from outside the anorectal tract
结局指标
主要结局
Fistula Closure (Patient Based)
时间窗: 12 months
Fistula closure is defined as absence of drainage at the external fistula opening.
Fistula Closure (Tract Based)
时间窗: 12 months
Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.
次要结局
未报告次要终点
研究者
研究点 (5)
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