URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 8
- 主要终点
- Primary Safety Endpoint defined as assessment of adverse events through 90 days
研究概览
简要总结
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
详细描述
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. The study is intended to assess the safety and efficacy of the Uriprene® Stent by assessing adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are >21, <80 years of age; inclusive of males and females.
- •Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
- •Subjects with asymptomatic, contralateral renal stones in sizes <4mm WHICH ARE NOT IN THE RENAL PELVIS OR URETER and who have had uncomplicated ureteroscopy (UURS) can be included. If, during the course of treatment of the target ureter with the Uriprene stent the patient's asymptomatic stone becomes symptomatic and requires treatment, the patient can only be managed with standard of care treatment including the use of an approved ureteral stent, if necessary.
- •Subjects 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.
- •Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and are willing to undergo all follow-up assessments according to the specified schedule.
排除标准
- •Subjects with a history of an anatomical abnormality of the urinary tract.
- •Presence of ureteral fistula.
- •Presence of urothelial cancer, ureteral tumor, or renal tumor.
- •Presence of extrinsic compression of the ureter.
- •Presence of ureteral blockage or stricture.
- •Bladder outlet obstruction or neurogenic bladder.
- •Subjects with known/diagnosed overactive bladder (OAB).
- •Subjects with known/diagnosed urge urinary incontinence (UUI).
- •Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion.
- •Subjects with creatinine level of ˃2.5 mg/dl.
- •Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
- •Impacted ureteral stones still in place and/or incomplete stone fragmentation.
- •Ureteral perforation.
- •Staghorn calculi.
- •Subjects with a solitary kidney.
- •History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed).
- •Contrast allergy that cannot be adequately pre-treated.
- •Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions or unable to reliably complete patient questionnaires.
- •Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.
- •Subject has a known significant concomitant illness with a life expectancy of <1 year.
- •Subject is known to be currently enrolled in another investigational trial.
结局指标
主要结局
Primary Safety Endpoint defined as assessment of adverse events through 90 days
时间窗: 90 days
Assessment of Adverse Events through the 90-day follow-up period (incidence, relationship to device and severity) compared to the historical control degradable ureteral stent and plastic ureteral stents
Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours
时间窗: 48 hours
Study Success defined as adequate short-term urine drainage, defined as the presence of the stent in the ureter and the lack of surgical or invasive intervention to treat symptoms in the stented ureter during the first 48 hours following placement.
次要结局
- Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.(90 days)
- Technical success of the device(90 days)
- Overall Clinical Success(90 days)