ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Rate of Treatment Related Serious Complication
研究概览
简要总结
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
详细描述
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB).
Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
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
- 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 or bladder neck contracture, less than or equal to 2.0 cm
- •One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision 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.
- •IPSS score of 13 or higher
- •Lumen diameter <12F by urethrogram
- •Able to complete validated questionnaire independently
- •Qmax <10 ml/sec
排除标准
- •Strictures greater than 2.0 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 and are unable to complete study required testing, such as uroflowmetry
- •Previous urethroplasty within the anterior urethra
- •Stricture due to bacterial urethritis or untreated gonorrhea
- •Stricture dilated or incised within the last 3 months
- •Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
- •Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator
- •Previous radical prostatectomy
- •Previous pelvic radiation
- •Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
- •Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL
- •Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.)
- •Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months
结局指标
主要结局
Rate of Treatment Related Serious Complication
时间窗: 90 days post-procedure
* urethral formation of fistula * de novo severe urinary retention lasting \> 14 consecutive days' post-treatment * unresolved de novo stress urinary incontinence (requiring \>1 pad/day) at 90 days or earlier * urethra rupture or burst.
次要结局
- Stricture Recurrence Rate(90 days post-procedure)