The Zenflow Spring System Safety and Performance Study (ZEST CAN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score
研究概览
简要总结
The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
详细描述
The purpose of the Zenflow Study (ZEST CAN) is to evaluate the safety, performance and effectiveness of the Zenflow Spring System for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hyperplasia (BPH). It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is able and willing to comply with all the assessments of the study
- •Patient or patient's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form
- •≥ 45 years of age
- •Baseline IPSS score > 13
- •Prostate volume 25 - 80 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days
- •Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS
排除标准
- •Obstructive intravesical median prostatic lobe which in the opinion of the operator would not benefit from treatment
- •Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilations as reported in the patient's history
- •Requiring self-catheterization to void.
- •Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
- •Any of the following, taken from a single uroflowmetry reading:
- •Post-void residual volume (PVR) > 250 ml
- •Peak urinary flow rate of > 15 ml/second
- •< 125 ml urinary volume voided at baseline (pre-bladder urinary volume of ≥150 ml required)
- •Other condition or disease that might cause urinary retention
- •History of other diseases causing voiding dysfunction
- •Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months)
- •Concomitant bladder stones
- •Previous pelvic irradiation or radical pelvic surgery
- •Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
- •Chronic prostatitis, or recurring prostatitis within the past 12 months
- •Known allergy to nickel
- •Life expectancy less than 24 months
- •Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function
- •Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (low dose aspirin therapy not prohibited).
- •Taking 5-alpha-reductase inhibitors within 3 months of pre-treatment (baseline) evaluation
- •Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:
- •alpha-blockers,
- •imipramine,
- •anticholinergics, or
- •cholinergic medication gonadotropin releasing hormonal analogs
- •Taking androgens, unless evidence of eugonadal state for at least 6 months.
- •Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
- •phenylephrine, or
- •pseudoephedrine
- •Future fertility concerns
- •Any concurrent medical condition or illness that might prevent study completion or would confound study results
结局指标
主要结局
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score
时间窗: 3 month
At 3 months, achieve at least 30% mean improvement in International Prostate Symptom Score (IPSS) compared to baseline. The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total IPSS score.
Incidence of procedure or device related serious adverse events
时间窗: 30 days after the procedure
Achieve \< 12% rate of device or procedure related SAEs through discharge and 30 days follow up.
Successful placement of the Zenflow Spring Implant
时间窗: Day of discharge up to 7 days following device placement
Number of successful deployments and procedural successes for the Zenflow System to implant the Spring device in the OR, or in an out-patient clinical setting as compared to total treatment attempts.
Need for urinary catheterization
时间窗: 7 days after the procedure
Achieve \< 12% rate of extended post-operative urinary catheterization, defined as an occurrence of a subject requiring catheterization within the first 3 days as part of a postoperative management for inability to void, for greater than 7 days.
次要结局
- Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10(Baseline, interoperative (if conscious sedation used), immediately post-treatment, 2 weeks, 1 and 3 months)
- Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score(Baseline, 3, 6, 12, 24, 36, 48, & 60 months)
- Assessment of Clavien-Dindo events(Up to 5 years)
- Assessment of Adverse Events(Up to 5 years)
- Assessment of PSA(Up to 5 years)
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)(24 to 60 months)