FENIX™ Continence Restoration System Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in fecal incontinence (FI) episodes
研究概览
简要总结
The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals being treated with the FENIX™ Continence Restoration System
- •Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
- •Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.
排除标准
- •Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy <5 years)
结局指标
主要结局
Change in fecal incontinence (FI) episodes
时间窗: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Proportion of participants with at least a 50% reduction in FI episodes per week
Change in fecal incontinence days
时间窗: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Proportion of participants achieving at least 50% reduction in FI days per week and urgent episodes
Adverse events related to the FENIX system
时间窗: assessed up to last follow up [max 60 months]
From the time of implant and at each follow-up visit, safety will be evaluated by characterizing adverse events (AEs) related to the FENIX system and summarizing incidence rates. Serious device-related AEs will be summarized separately.
Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.
时间窗: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Proportion of patients with improvement in Fecal Incontinence Quality of Life (FIQOL) score. The Fecal Incontinence Quality of Life Scale consists of 29 items divided into 4 scales: * Lifestyle (10 items) * Coping/Behavior (9 items) * Depression/Self Perception (7 items) * Embarrassment (3 items) Scales range from 1 to 5, scale scores are the average (mean) of all responses to all items in each scale. A lower score indicated a lower quality of life. The scales are not combined for a "composite" or total score but always presented individually.
次要结局
未报告次要终点