NCT02428595已完成不适用
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 22
- 主要终点
- Count of Treatment Responders in the Intent to Treat (ITT) Cohort
研究概览
简要总结
Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of Fecal Incontinence (FI) for at least 6 months
- •Subject willing and able to give written informed consent to participate in the study
- •Subject can read, write and communicate fluently in English
- •Subject willing and able to comply with visit schedule
- •Subject is able to physically manage the insertion and removal of the Insert
- •Abbreviated
排除标准
- •Vaginal childbirth within the last 18 months
- •Currently pregnant or planning pregnancy during the study period
- •Acute infections or genito-urinary injuries that would impact comfortable device use
- •Current treatment for Fecal Incontinence other than medical management
- •Removal or diversion of any portion of the bowel
- •Recent urogenital or colorectal surgeries
- •Chronic abdominal pain in absence of diarrhea
- •Chronic (>6 mos) rectal, anal or pelvic pain
- •Chronic watery diarrhea, unmanageable by drugs or diet
- •Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis
- •Rectal prolapse (mucosal or full thickness)
- •Grade III or IV hemorrhoids
- •Pelvic organ prolapse beyond the plane of the hymen
- •Concurrent use of intra-vaginal pessary or other device
- •Anal or pelvic malignancy within last 5 years
- •History of pelvic irradiation for cancer
- •Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk
研究组 & 干预措施
Treatment
Experimental
Eclipse™ System
干预措施: Eclipse™ System (Device)
结局指标
主要结局
Count of Treatment Responders in the Intent to Treat (ITT) Cohort
时间窗: 3 months
Count of patients with \>50% reduction in the average number of FI episodes per week as compared to baseline.
次要结局
- Count of Treatment Responders in the Per Protocol (PP) Population(3, 6 and 12 months)
- Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline(12 months)
- Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline(12 months)
- Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores(3, 6, 9 and 12 months)
研究者
研究点 (22)
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