NCT06136312已完成不适用
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Evaluable biopsies
研究概览
简要总结
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
详细描述
The overall purpose of this study is to confirm performance and safety of Multi4 Medical Device System when used as intended: to cauterize, remove, and automatically collect multiple tissue samples through the working channel of an endoscope.
The safety profile will be documented by collecting data on frequency and severity of complications, AEs such as bleeding and perforations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Previous bladder cancer Ta/T1 G1-3
- •Recurrence of urinary superficial/ non-muscle-invasive bladder cancer visible at cystoscopy, estimated size < 10 mm
- •Willingness and ability to provide informed consent
- •Age ≥18 years
排除标准
- •Implantable Cardioverter Defibrillator (ICD) that cannot be inactivated
- •Current/ongoing untreated urinary tract infection
- •Pregnancy or breastfeeding
- •Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation
结局指标
主要结局
Evaluable biopsies
时间窗: At procedure
Biopsies collected by the instrument are evaluable by pathologist
次要结局
- Time to perform procedure(At procedure)
- Number of patients with complete procedures performed(At procedure)
- Time for patient surveillance(At procedure)
- Number of participants with treatment-related adverse events(One week)
- Cost effectiveness(At procedure)
- Patient-reported treatment-related pain (numeric rating scale)(At procedure)
- Operator-reported ease of use(At procedure)
- Quality of life (EQ-5D-5L)(At procedure and after 1 week)
- Self reported satisfaction with procedure(One week)
研究者
研究点 (1)
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