Clinical Investigation to Evaluate the Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ambu A/S
- 入组人数
- 83
- 试验地点
- 4
- 主要终点
- Performance of the cystoscope
研究概览
简要总结
In this study, the new aScope 4 Cysto is used to see if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes. This study will be done in patients who come to the clinic for either a diagnosis of their urethra and bladder or for a small intervention. For an intervention a lesion or tumor is resected, a stent in the ureter is taken out, or an injection in the bladder wall is given. The flexible cystoscope is passed into the urethra and bladder for visual inspection of the bladder and urethra. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present. If an intervention is performed the aScope 4 Cysto will be used with an endoscopic accessory.
详细描述
Clinical Phase: pre-CE study
Design: A prospective, multicenter, single- arm open-label clinical study on the performance and safety of Ambu® aScope™ 4 Cysto and aView™ Urologia, a single-use, flexible cystoscope for flexible cystoscopy
Population: Adult subjects (≥ 18 years) undergoing flexible cystoscopy for diagnostic or therapeutic purposes.
Planned Sample Size: A total of 80 patients will result in a maximum (if the true proportion is 50 %) width (i.e. the difference between the point estimate and the upper, or lower, limit of the confidence interval) of the two-sided 95 % confidence interval for the binary variable "Performance level acceptable" to be 11%. This width is considered to be useful in the interpretations of the results from this part of the trial.
Study duration: Screening, procedure and follow-up will take 14 days maximum. A follow-up telephone call at 7 days post procedure is performed to record any adverse events post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (males and females), ≥18 years of age or older, presenting for cystoscopy
- •Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes
- •Willing to participate in a clinical trial
排除标准
- •History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes
- •History of prior bladder/urethral reconstructive surgery
- •Presence of symptomatic urinary tract infection (UTI)
- •Known unpassable urethral stricture
- •Unable to read and/or understand the study requirements
- •Unable or unwilling to provide consent to participation in the study
- •Pregnant or lactating women
结局指标
主要结局
Performance of the cystoscope
时间窗: follow up immediately after procedure
Rate of completion of procedure with Ambu® aScope™ 4 Cysto and aView™ Urologia (yes/no, yes applies to 80% of the procedures)
次要结局
- Patient Tolerance(follow up immediately after procedure)
- Adverse events(follow-up at 7 days after procedure)
- Overall performance(follow up immediately after procedure)
- Procedure time(follow up immediately after procedure)