NCT05708612进行中（未招募）不适用
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Safety-related complications and adverse events
研究概览
简要总结
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female subjects
- •Age ≥ 18 years, <85 years
- •Subject has failed standard conservative therapy for fecal incontinence (at least 6 months)
- •Subject is a surgical candidate
- •Subject is willing and able to cooperate with follow-up examinations
- •Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.
排除标准
- •Treatment with another investigational drug or investigational device
- •Unable to understand study requirements or is unable to comply with follow-up schedule
- •Contraindicated according to the instruction for use of the device
- •Pregnancy or nursing, or plans to become pregnant
- •History of significant obstructed defecation or other significant chronic defecatory motility disorders
- •Current, external full thickness rectal prolapse or vaginal prolapse
- •Inflammatory Bowel Disease
- •Irritable Bowel Syndrome
- •Systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)
- •Active pelvic infection
- •Chronic diarrhea
- •Medical history of anal, rectal, or colon cancer
- •Prior anterior resection of the rectum
- •Medical history of pelvic radiation therapy
- •Significant scarring of the recto-vaginal septum, a permanent implant in the rectovaginal septum, or a history of recto-vaginal fistula
- •Previous anorectal posterior compartment surgery
- •History of complex anal fistula
结局指标
主要结局
Safety-related complications and adverse events
时间窗: 12 months
The primary endpoint is safety-related complications and adverse events during follow-up until 12 months after surgery.
次要结局
- Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs))(12 months)
- Quality of Life (St. Mark's incontinence score (SMIS))(12 months)
研究者
研究点 (5)
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