Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

A.M.I. Agency for Medical Innovations GmbH5 个研究点分布在 3 个国家目标入组 36 人2023年4月1日

适应症Fecal Incontinence

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Fecal Incontinence
发起方: A.M.I. Agency for Medical Innovations GmbH
入组人数: 36
试验地点: 5
主要终点: Safety-related complications and adverse events
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2023年4月1日

结束日期

2026年9月1日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

A.M.I. Agency for Medical Innovations GmbH

责任方

Sponsor

入排标准

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

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)