URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.
详细描述
Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment.
Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are > 18, < 80 years of age; inclusive of males and females.
- •Patients with unilateral ureteral or renal stone fragments < 2mm, post-uncomplicated ureteroscopy (UURS).
- •Patients with a height and body size able to accommodate a 20, 22, 24, 26, 28, or 30 mm long ureteral stent, as judged by the Investigator.
- •Patients with the ability to understand the requirements of the study, who have provided written informed consent, and who have agreed to return for the required follow-up assessments.
排除标准
- •Patients with a known contraindication for treatment with the Uriprene® Stent.
- •Patients with a history of an anatomical abnormality of the urinary tract.
- •Patients with a known upper or lower urinary tract infection at the time of stent insertion.
- •Patients with known renal insufficiency or chronic impairment.
- •Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent.
- •Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator.
- •Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent).
- •Presence of ureteral blockage or stricture
- •After failed guide wire placement or failed ureteroscopic access
- •Impacted ureteral stones still in place
- •Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy
- •Patients with a solitary kidney
- •Presence of ureteral fistula
- •Presence of ureteral tumor
- •Presence of extrinsic compression of the ureter
- •Urinary tract infection
- •Staghorn calculi
结局指标
主要结局
Safety
时间窗: 90 days
Composite of new-onset serious adverse event(s) including death, infection, the occurrence of surgery, re-hospitalization and or repeat hospitalization related to the device, or device related injury of the ureter.
次要结局
- Technical Success(90 days)
- Pain(90 days)