Clinical Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Successful Acute Performance- III
研究概览
简要总结
The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and extended period (up to 29 days) of home use.
详细描述
The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in male patients 18 years of age or older who have impaired bladder emptying due to neurogenic lower urinary tract dysfunction, and who are capable of operating the device in accordance with the provided instructions for use, or who have trained caregivers capable of doing the same. The device must be replaced every 29 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)
- •Must be clinically suitable and capable of safely managing bladder using an intermittent voiding strategy Must have stable urinary management history with clean intermittent catheterization: no significant changes in bladder management regimen within past 12 months
- •Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions)
- •Subject's lower urinary tract anatomy (lengths of proximal and distal urethral must fall within the ranges serviceable by the Connected Catheter device, as specified in the investigational device instructions for use.
- •For cases of NLUTD due to spinal cord injury, the subject must be in medically stable condition (i.e. post-spinal shock phase)
排除标准
- •Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the CoCath Device after UTI has been treated)
- •Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
- •Significant risk profile or recent history of clinically significant autonomic dysreflexia (e.g. History of hospitalization due to AD within past 12 months)
- •Significant intermittent urinary incontinence (between catheterizations)
- •Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. botox injections)
- •Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy, urine analysis, and blood labs)
- •Urinary tract inflammation or neoplasm
- •Urinary fistula
- •Bladder diverticulum (outpouching) > 5cm in size
- •Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
- •Impaired kidney function or renal failure (assessed via blood creatinine levels > 2 mg/dL)
- •Active gross hematuria
- •Active urethritis
- •Bladder stones
- •Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
- •Individuals allergic or otherwise unable to take oral antibiotics
- •Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the CoCath System
研究组 & 干预措施
Connected Catheter Feasibility Study
Clinical Feasibility Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
干预措施: Connected Catheter (Device)
结局指标
主要结局
Successful Acute Performance- III
时间窗: On the day of Connected Catheter Insertion
To evaluate successful removal of Connected Catheter
Successful Acute Performance- I
时间窗: On the day of Connected Catheter Insertion
To evaluate successful retention of Connected Catheter and Void
Successful Acute Performance -II
时间窗: On the day of Connected Catheter Insertion
To evaluate successful bladder voiding with Connected Catheter
Successful Acute Performance- IV
时间窗: On the day of Connected Catheter Insertion
To evaluate successful post-void sealing of Connected Catheter Valve
Successful Home-Use Performance
时间窗: 29 days
Successful Home-Use using same measures as Acute Performance
Freedom from genito-urinary injury/trauma
时间窗: 29 Days
Improved bladder management without injury or trauma to genito-urinary tract
次要结局
未报告次要终点