NCT03972371已完成不适用
The ProVerum First in Man PROVE Study
ProVerum Medical1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年5月13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
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Deployment of the Implant
研究概览
简要总结
A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥ 50 years of age
- •Moderate-to-severe symptomatic BPH
- •IPSS of > 15
- •Peak urinary flow rate (Qmax) of <12 mL/s
- •Prostate volume of ≥ 30 and ≤80 cc
- •Prostatic urethral lengths ≥ 4cm
排除标准
- •A prostatic urethral length of less than 4cm
- •A prostatic volume <30cc or >80cc
- •An obstructing intravesical prostatic median lobe
- •Urinary incontinence due to an incompetent external sphincter
- •Urethral pathologies that may prevent insertion of delivery system
- •A current symptomatic urinary tract infection
- •Current significant visible haematuria
- •Patients with known allergy to nickel or titanium
- •History of significant medical co-morbidity or prior surgery that may confound the results of the Study
- •Another medical condition that would pose an unacceptable patient risk
- •Known or suspected urological condition that may affected voiding function
- •Neurogenic bladder and/or sphincter abnormalities
- •Patients with cognitive disabilities unable to understand and give informed consent to the research study
结局指标
主要结局
Deployment of the Implant
时间窗: Immediately after the implant deployment procedure
Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment endoscopy
Expansion of the Implant
时间窗: Within 24 hours of the implant deployment procedure
Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT
次要结局
- Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms(2 years)
- Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period(Immediately after the implant deployment procedure, within 24 hours)
- Preliminary assessment of the effectiveness of the procedure in improving urinary flow(2 years)
- Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years(2 years)
研究者
研究点 (1)
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