NCT04197583已完成不适用
Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 10
- 主要终点
- Percentage of Implanted Stents Meeting the Technical Success Criteria
研究概览
简要总结
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
详细描述
A multi-center registry study to obtain post-market clinical data on safety and effectiveness of the Boston Scientific Ureteral and Urinary Diversion Stents
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
- •(for all Ureteral stent types except Urinary Diversion Stents):
- •Subject is undergoing placement of a Boston Scientific Ureteral Stent
- •Subject anatomy is appropriate to accommodate a stent size available in the study
- •Subject is able to accurately detect and report bladder function and pain
- •Subject is willing and able to:
- •Complete patient QoL questionnaire at specified time points (for subjects aged ≥ 18 years)
- •Return for all follow-up visits
- •Inclusion Criteria (for Urinary Diversion Stents):
- •Subject is undergoing placement of a Boston Scientific Urinary Diversion Stent(s)
- •The anatomical features of the involved renal collecting system are known by either prior or concurrent urography or axial CT imaging
- •Subject is willing and able to return for all follow-up visits
排除标准
- •(for Ureteral stents and Urinary Diversion Stents):
- •Subjects who meet any of the contraindications per individual stent DFU
- •Subjects receiving different stent type in case of bilateral/multiple stenting
- •Subjects with an indwelling ureteral stent(s) not planned to be removed prior to/or concurrently with the study stent implant
结局指标
主要结局
Percentage of Implanted Stents Meeting the Technical Success Criteria
时间窗: 2 months to 15 Months
Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters.
Primary Safety Endpoint
时间窗: 2 months to 15 Months
Any Serious Adverse Device Effects
次要结局
- Quality of Life - Patient-Reported Outcomes(Change From Index Procedure to Stent Removal Visit; Change From Index Procedure to Post Stent Removal Visit Stent Removal: Typically, within 2 weeks to < 365 days from Index Procedure Post-Stent Removal: Typically, 3 - 12 weeks from Stent Removal)
- Stent Migration(2 months to 15 Months)
研究者
研究点 (10)
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