NCT07564102尚未招募1 期
dMD-002 US Pilot Study A Single-center, Randomized, Double-blind, Pilot Study to Assess the Efficacy and Safety of dMD-002 in Patients After Radical Prostatectomy
Mochida Medical USA, Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean IIEF-EF scores
研究概览
简要总结
The purpose of this study is to conduct a US Pilot study of dMD-002 as a peripheral nerve repair sheet in patients with cavernous nerve injury following radical prostatectomy. The study will determine which endpoints and timepoints will be used for the pivotal study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with prostate cancer.
- •Patients scheduled to undergo a robot-assisted radical prostatectomy (including either bilateral-nerve sparing or unilateral-nerve sparing) for treatment of prostate cancer.
排除标准
- •Patients undergoing pre-surgery or post-surgery radiation therapy, hormone therapy, or anti-cancer therapy.
- •Patients who have used a penile prosthesis implantation.
- •Patients with a history of transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, cryoablation, or other prostate surgery.
研究组 & 干预措施
Treatment group
Experimental
干预措施: dMD-002 (Device)
Control group
Sham Comparator
干预措施: Control (Other)
结局指标
主要结局
Mean IIEF-EF scores
时间窗: 6 months postoperatively
次要结局
- Mean EHS score(Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months)
- Mean SHIM score(Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months)
- 24-hour pad weight test(Screening, 6 weeks, and 3 months)
- Number of Incontinence Episodes/Day(Screening, 6 weeks, and 3 months)
研究者
研究点 (1)
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