NCT00703131已完成不适用
A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Healing Success
研究概览
简要总结
The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.
详细描述
Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric
- •Signed informed consent
- •Willing to return for follow-up visits
排除标准
- •Crohn's Disease
- •Ulcerative Colitis
- •HIV Positive
- •Immune System Disorder
- •Collagen Disorder
- •Tuberculosis
- •History of radiation to anorectal region
- •Allergies to pig tissue
- •Religious or cultural objection to use of pig tissue in this surgical application
- •J-pouch fistulas
- •Previous Surgisis AFP Plug placement in target fistula tract
- •Tracts with acute abscess, infection or inflammation
- •Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy
结局指标
主要结局
Healing Success
时间窗: 12 months
次要结局
- Change in Quality of Life Measures(3, 6, and 12 months)
研究者
研究点 (1)
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