A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Fit Rate
研究概览
简要总结
A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.
详细描述
Up to 150 subjects enrolled, in up to 25 sites. Population of all adult female patients with Fecal Incontinence (FI) who present at, or are identified at, participating sites are eligible. This includes patients who are newly prescribed Eclipse, and those already using Eclipse who return for an annual renewal visit during the enrollment period.
Includes fitting of the patient for the Eclipse System with collection of relevant health history data. Patients are provided a temporary device for a trial usage period. Multiple device sizes may be attempted to find the correct fit for the patient, at which point the patient is provided with the long term use Eclipse Insert and enters the treatment period.
During the fitting and treatment period, patient experience will be assessed by surveys, St. Mark's (Vaizey) scores, and the validated global PGI-I index (Patient Global Impression of Improvement). Surveys will be perform at the fitting follow up and at 12 months of device usage, and optionally at 3, 6, and 9 months of device usage.
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
- •Adult female
- •Diagnosis of Fecal Incontinence
- •Clinician recommendation of the Eclipse System
- •Subject provides informed consent and HIPAA authorization
- •No Exclusion Criteria.
排除标准
- 未提供
研究组 & 干预措施
Treatment
All patients fitted with the device.
干预措施: Eclipse Insert (Device)
结局指标
主要结局
Fit Rate
时间窗: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Proportion of patients successfully fit
Device Size Distribution
时间窗: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Size distribution of devices among successfully fit patients
St. Mark's Score (Vaizey)
时间窗: 12 months
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
PGI-I Score
时间窗: 12 months
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
次要结局
- PGI-I Score(9 months)
- St. Mark's Score (Vaizey)(9 months)