NCT03270384已完成不适用
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Safety- Rate of Device Related Serious Complications
研究概览
简要总结
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects ≥ 18 years' old
- •Visual confirmation of stricture via cystoscopy or urethrogram
- •Single lesion anterior urethral stricture less than or equal to 3 cm
- •Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty
- •Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections).
- •IPSS (International Prostate Symptom Score) score of 13 or higher
- •Lumen diameter <12F by urethrogram
- •Able to complete validated questionnaire independently
- •Qmax <12 ml/sec
- •Guidewire must be able to cross the lesion
排除标准
- •Strictures greater than 3.0 cm long.
- •Subjects that have more than 1 stricture.
- •Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- •Subjects who have a suprapubic catheter
- •Previous urethroplasty within the anterior urethra
- •Stricture due to bacterial urethritis or untreated gonorrhea
- •Stricture dilated or incised within the last 3 months
- •History of over active bladder or stress incontinence
- •Previous radical prostatectomy
- •Previous pelvic radiation
- •Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
- •Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
- •Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
研究组 & 干预措施
Treatment
Experimental
Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)
干预措施: Urotronic Drug Coated Balloon (DCB) (Device)
结局指标
主要结局
Safety- Rate of Device Related Serious Complications
时间窗: 90 days
次要结局
- Efficacy- Stricture Recurrence Rate(6 months)
- Safety- Change in IIEF (International Index of Erectile Function)(90 days)
研究者
研究点 (5)
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