Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 主要终点
- The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
研究概览
简要总结
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions.
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of fecal incontinence;
- •Incontinence episodes over a 14-day period;
- •Eighteen years of age or older;
排除标准
- •Abnormalities of the external sphincter greater than 10 mm;
- •Fibrosis of the tissue at the likely injection sites;
- •Has a condition that could lead to significant postoperative complications
- •Rectal varices;
- •Cancer of the rectum or colon, undergoing active treatment;
- •Crohn's disease or ulcerative colitis;
- •Chronic diarrhea unmanageable by drugs and/or diet;
- •Rectal bleeding;
- •Pregnant or within one year postpartum.
结局指标
主要结局
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
时间窗: 6 month
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
时间窗: Throughout study
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
时间窗: 12 month
次要结局
未报告次要终点