Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 8
- 主要终点
- The change in Post Void Residual from baseline to day 28 will be measured and reported
研究概览
简要总结
The Investigators will study a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual > 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual <75 cc.
详细描述
The indication for use of the Blue Halo Coil Catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. The device is inserted for temporary use up to 28 days.
Study participants will have a history of Foley catheter use or self-catheterization to drain their bladder.Participants may include men in urinary retention with no prior intervention.
The hypothesis is that the Blue Halo Coil Catheter will reduce the post void residual to <75 cc with volitional voiding.
The Blue Halo Coil Catheter is comprised of a Coiled Retention portion with a guidewire accommodating tip, a short prostate catheter segment, and a pusher/delivery catheter segment, that when left in place allows for the temporary collection of urine prior to conversion to short segment without an external collection device. The tip of the Blue Halo Coil Catheter utilizes a horizontal coil retention device. A monofilament suture is attached to the prostate catheter segment to allow for ease of positioning and removal. The suture also allows for repositioning should the device slip back into the bladder.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects > 50 years of age
- •Able to provide consent
- •Participants in urinary retention with post void residual > 350 cc
- •Urinary retention is due to BPH with a prostate volume > 50cc or a prostatic urethral length of 5+ cm
- •Subjects with a PSA > 4 ng/ml and a PSA density of 0.1 or less
- •Subjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be included
- •Exclusion Criteria
- •Inability to undergo bladder catheterization ( i.e. urethral stricture)
- •Presence of gross hematuria
- •Lack of cognitive ability to give consent or keep appointments
- •History of Prostate Cancer
- •Subject with a PSA > 4 ng/ml and a PSA density of > 0.1 will require prostate biopsy to rule out prostate cancer in order to be considered for study enrollment
- •A subject with a prostate nodule will require biopsy to exclude cancer diagnosis
- •Subject with a PSA > 10 ng/ml
- •Subject taking LHRH analogs or anti-androgen drugs
排除标准
- 未提供
结局指标
主要结局
The change in Post Void Residual from baseline to day 28 will be measured and reported
时间窗: 28 days
The primary effectiveness endpoint of the study is the number of subjects who were able to return to volitional voiding with a post void residual less then 75 cc during a 28-day study period.Post Void Residual will be measured by bladder ultrasound and reported as cc.
次要结局
- Secondary Safety Endpoint 1, incidence of device encrustation at removal(28 days)
- Secondary Safety Endpoint 2,urinary obstruction due to device migration(28 days)
- Secondary Safety Endpoint 3, incidence of clinically significant hematuria(28 days)
- Primary safety endpoint adverse event and device removal(28 days)