NCT01462747已完成2 期
An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas
Nordic Drugs AB4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Clinical evaluation of fistula healing, change from baseline
研究概览
简要总结
The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
详细描述
Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.
Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
- •Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
- •Superficial fistula involving a part of the external sphincter muscle
- •Age: ≥18 years and ≤ 75 years
- •Informed consent and/or Letter of Authority (as applicable) obtained
排除标准
- •Inflammatory Bowel Disease (IBD)
- •Rectovaginal fistulas
- •Rectourethral fistulas
- •Rectovesical fistulas
- •Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
- •Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
- •Any surgical treatment for perianal fistulas
- •Colorectal and/or anal malignancy
- •Other malignancy requiring active treatment
- •Subcutaneous fistulas not involving any part of the external sphincter
- •Other diseases which as per the investigator's opinion should be contraindicated
- •Subjects who are not able to complete study procedures as per the investigator's opinion
结局指标
主要结局
Clinical evaluation of fistula healing, change from baseline
时间窗: week 8 and 24
Fistula assessed as healed/not healed
次要结局
- Anal ultrasonography, change from baseline(week 8 and 24)
- Patient assessment of Symptoms and Impact on Daily Function, change from baseline(week 8 and 24)
- Safety, change from baseline(week 2, 8, 24)
研究者
研究点 (4)
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