CTRI/2014/12/005238招募中不适用
PROCEPT AQUABEAM Study for the treatment of Benign Prostatic Hyperplasia (ABS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Device performance outcome:
研究概览
简要总结
| This is Single-arm, prospective, interventional clinical trial. PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The AQUABEAM® System is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS). |
Each subject is followed for 12 months (1 year) postoperatively. Enrollment is expected to take up to 3 months. Total study duration is 27 months.
The target patientpopulation is patients with symptomatic BPH who have not responded adequatelyto standard medical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •The target patient population is patients with symptomatic BPH who have not responded adequately to standard medical therapy. Inclusion Criteria a) Male b) Age
- •80 years c) Prostate size ≥ 25 g and ≤ 120 g d) IPSS score > 12 e) Qmax ≤ 15ml/s f) History of inadequate response,contraindication or refusal to medical therapy g) Patient is mentally capable and willingto sign a study-specific informed consent form h) Patient is willing and able to complywith all study requirements i) Schaffer scale ≥Grade 2.
排除标准
- •a) History of, current or suspected prostate/bladder cancer b) Elevated PSA (age 50-70 PSA ≥4; age 70-80 PSA ≥6.5) unless negative biopsy within last 3 months or positive biopsy c) Neurogenic bladder d) Prostatitis treated with antibiotics within 1 year of enrollment e) Current Urethral stricture, meatal stenosis, or bladder neck contracture f) Previous prostate surgery g) Significant Renal impairment h) Active infection, including urinary tract infection i) Patients on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy j) Gross haematuria k) Known allergy to device materials l) Any severe illness that would prevent complete study participation or confound study results m) Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure – NYHA Class IV), pulmonary disease or uncontrolled diabetes.
- •n) Participants using immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents(NSAIDs, including aspirin) for 14 days prior to treatment; Known illicit substance abuse o) Dementia or psychiatric condition that prevents the participant from completing required follow up p) Contraindication to general anesthesia q) Participating in another investigational study that could affect responses to the study device.
结局指标
主要结局
Primary Device performance outcome:
时间窗: On the day of surgery.
•Completion of the intended surgical procedure
时间窗: On the day of surgery.
Primary Safety outcome:
时间窗: On the day of surgery.
•Peri-operative complication rate.
时间窗: On the day of surgery.
次要结局
- • Change from baseline in International Prostate System Score, International Index of Erectile Function.(From baseline to study completion.)
- • Change from baseline in peak urinary flow rate, post-void residual volume and PDet@Qmax (Schaffer grade)(Baseline and 6 months.)
- Additional outcomes include:(• Proportion of subjects and period of Foley catheter placement postoperatively: Baseline and 1 week)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
AQUABEAM India Study for the Treatment of Benign Prostatic HyperplasiaBenign Prostatic HyperplasiaNCT03167294PROCEPT BioRobotics47
进行中（未招募）
不适用
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTsLocalized Prostate CancerBenign Prostatic HyperplasiaNCT06051942PROCEPT BioRobotics125
进行中（未招募）
不适用
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic SystemLocalized Prostate CancerNCT06054867PROCEPT BioRobotics22
已完成
不适用
Valvosoft First-In-Human Study in Severe Symptomatic Aortic StenosisAortic Valve StenosisNCT04665596Cardiawave SA10
已完成
不适用
Valvosoft First-In-Man Study in Severe Symptomatic Aortic StenosisAortic Valve StenosisNCT03779620Cardiawave SA30