Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 18
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
详细描述
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects between 22 and 65 years of age
- •Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use
- •Subject is willing to provide written informed consent and comply with study required follow-up assessments
- •Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
- •total sperm ≥39 million
- •sperm concentration ≥15 million/mL
- •total motility ≥40%
- •progressive motility ≥32%
- •morphology ≥4%
排除标准
- •Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
- •Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- •Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- •Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- •Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- •History of cancer in any body system that is not considered in complete remission
研究组 & 干预措施
Optilume Urethral DCB
The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
干预措施: Optilume Urethral DCB (Combination Product)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 3-months
Average Change in Sperm Concentration from baseline to 3-months
次要结局
- Secondary Safety Endpoint(6-months)