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临床试验/NCT04192474
NCT04192474已完成不适用

Clinical Investigation to Evaluate the Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

Ambu A/S4 个研究点 分布在 2 个国家目标入组 83 人开始时间: 2020年7月21日最近更新:
适应症

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

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)

研究者

发起方
Ambu A/S
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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