Flexiva Pulse Laser Fiber Post-Market Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 4
- 主要终点
- Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
研究概览
简要总结
To obtain post-market safety and efficacy data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).
详细描述
Multi-center, open label, prospective study to document on-going post-market safety and performance of Flexiva Pulse High Power Single-Use Laser Fibers.
All subjects meeting the enrollment criteria, signing the consent and undergoing the lithotripsy/HoLEP procedure with the study device(s) will be followed: up to 2 months (60 days) post-discharge from final holmium laser lithotripsy procedure for subjects in the lithotripsy cohort or up to 6 months (180 days + 60 days) post discharge from HoLEP procedure for subjects in the Benign Prostatic Hyperplasia (BPH) cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Lithotripsy cohort:
- •Subject is undergoing treatment for urinary calculi
- •Subject is willing and able to return for all follow-up visits
- •For BPH cohort:
- •Subject is ≥ 40 years of age
- •Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
- •IPSS (International Prostate Symptom Score) ≥ 12
- •Qmax (Peak Flow Rate) ≤ 15 mL/s
- •Subject is willing and able to return for all follow-up visits
排除标准
- •For Lithotripsy cohort:
- •Subject has uncontrolled bleeding disorders and coagulopathy
- •Subject has untreated urinary tract infection (UTI)
- •Subject requires simultaneous HoLEP procedure
- •For BPH cohort:
- •Subject has a diagnosis of bladder cancer
- •Subject has a diagnosis of prostate cancer
- •Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy
- •Subject has acute prostatitis, a prostate abscess, or neurogenic bladder
- •Subject has urethral stricture disorder
- •Subject has uncontrolled bleeding disorders and coagulopathy
- •Subject has untreated urinary tract infection (UTI)
- •Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
结局指标
主要结局
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
时间窗: Up to 240 days of follow-up for BPH Cohort.
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures.
Stone Free Rates - Primary Efficacy Endpoint 1
时间窗: 1 month follow-up
In lithotripsy procedures: Stone clearance assessed by stone free rates (SFR) at the 1 month follow-up. Stone free was defined as clinically nonsignificant, non-obstructive residual fragments of ≤ 3 mm, asymptomatic, and no auxiliary procedures performed between the final Flexiva Pulse holmium laser lithotripsy procedure and the 1-month follow-up.
Change in BPH Symptoms - Primary Efficacy Endpoint 2
时间窗: 3 month follow-up
In HoLEP procedures: Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3 month follow-up, on a scale of 0 to 35.
次要结局
- Procedure Related AEs and/or ADEs - Secondary Safety Endpoint(Up to 240 days of follow-up for BPH Cohort.)
- Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1(Through lithotripsy procedure completion, up to 1 day.)
- Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2(Through HoLEP procedure completion, up to 1 day.)
- Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1(Through lithotripsy procedure completion, up to 1 day.)
- Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2(Through HoLEP procedure completion, up to 1 day.)
- Change in Uroflowmetry - Secondary Efficacy Endpoint 2(Up to 3 month follow-up)
- Change in Quality of Life - Secondary Efficacy Endpoint 2(Up to 3 month follow-up)
- Hemostasis - Secondary Efficacy Endpoint 2(Through HoLEP procedure completion, up to 1 day.)