Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® aView™ 2 Advance for Flexible Cystoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.
研究概览
简要总结
The purpose of this study is to evaluate the use of the single-use Ambu® aScope™ 4 Cysto for removal of ureteral stents as compared to routine flexible reusable cystoscopes.
详细描述
This study is a prospective, randomized, multi-center, post-market investigation of the effectiveness of Ambu® aScope™ 4 Cysto (single-use cystoscope) as compared to routine flexible reusable cystoscopes (standard of care) for ureteral stent removals. The investigation will include approximately 102 subjects (randomized at a 1:1 ratio).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult (male or female), ≥18 years old
- •Patient undergoing routine flexible cystoscopy
- •Patient with a ureteral stent in the urinary system that is ready to be removed.
- •No active urinary tract infection
- •Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol.
排除标准
- •History of prior bladder/urethral reconstructive surgery.
- •History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes.
- •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
- •Patient is unable to read and/or understand study requirements
- •Patient is unable or unwilling to provide written consent to participate in the study.
- •Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not
研究组 & 干预措施
Ambu® aScope™ 4 Cysto
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
干预措施: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal (Device)
Standard of Care (SOC)
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
干预措施: Standard of care reusable cystoscope used for stent removal (Device)
结局指标
主要结局
The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.
时间窗: Procedure Date (Day 0)
Stent removal procedural success rate with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance.
次要结局
- Comparison of Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting to standard of care reusable scopes on scope performance.(Procedure Date (Day 0))
- Safety Endpoints(7-10 Days Post-Procedure)
- To evaluate the user experience during cystoscopic procedures.(Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).)
- Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope.(Procedure Date (Day 0))