Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Cumulative Procedure Time
研究概览
简要总结
This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.
详细描述
This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged at least 18 years old
- •Patient undergoing routine flexible cystoscopy
- •No active urinary tract infection
- •Subject is willing and able to sign informed consent and HIPAA authorization.
排除标准
- •Known unpassable urethral stricture
- •Febrile patient with active urinary tract infection (UTI)
- •Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
- •Subject with severe coagulopathy
- •Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
研究组 & 干预措施
Control
Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.
干预措施: Cystoscopy with standard of care flexible reusable scope (Device)
Intervention
Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.
干预措施: Cystoscopy with RedPine flexible disposable cystoscope (Device)
结局指标
主要结局
Cumulative Procedure Time
时间窗: 30 minutes
To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by: * Scope preparation for procedure * Actual procedure time (insertion of cystoscope to complete bladder examination) and * Time to dispose of or prepare for reprocessing of cystoscopy equipment.
次要结局
- User experience and product performance during cystoscopic procedures(within 24 hours)
- Participant comfort during the procedure(30 minutes)
- RedPine Cystoscope Conversion Rate(30 minutes)
- Device Failure Rate(30 minutes)
研究者
Yair Lotan, MD
Professor Vice Chair of Clinical Affairs Chief of Urologic Oncology
University of Texas Southwestern Medical Center