Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of the utility and performance of the cystoscope by the physician
研究概览
简要总结
This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.
详细描述
A new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. The cystoscope, named the Uro-C, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (LCD) monitor. Cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used.
This is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
- •Ambulatory and able to undergo routine cystoscopy in the lithotomy position.
排除标准
- •History of prior bladder/urethral surgery other than TURBT; or
- •History of interstitial cystitis; or
- •Presence of urinary tract infection (UTI); or
- •Gross hematuria; or
- •History of pelvic radiation therapy; or
- •Procidentia; or
- •Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
- •Unable or unwilling to provide consent to participation in the study.
结局指标
主要结局
Assessment of the utility and performance of the cystoscope by the physician
时间窗: during the procedure
Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device
次要结局
- Patient tolerance of the procedure(during and within 5 days after the procedure)