The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Successful placement of the Zenflow Spring Implant
研究概览
简要总结
This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
详细描述
A multi-center, prospective, single arm safety, performance, and effectiveness trial. The study will be conducted in two stages. Upon the successful completion of stage 1, the study will be expanded and continue to stage 2.
Stage 1 will enroll subjects in the Intent to Treat (ITT) cohort. The purpose of stage 1 is to assess acute safety and performance of the Zenflow System at the time of the procedure, through discharge, 2 weeks and 1 month, in up to 10 subjects enrolled at up to 7 investigational sites, to determine continuation to stage 2.
Upon successful completion of stage 1, the study will be expanded to stage 2 with sites added and continued enrollment in the ITT cohort. All subjects, including those enrolled in the stage 1 evaluation, will continue to be followed at all the designated follow-up time points for the full duration of the study (60 months).
Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (60 months), or until exited.
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
- •All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- •≥ 45 years of age
- •Baseline IPSS score > 13, and a baseline Quality of Life (QoL) question score > 3
- •Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS), measured within past 90 days and prostatic urethral length between 2.5-4.5 cm.
- •Failed or intolerant to medication regimen for the treatment of LUTS.
排除标准
- •Subjects will be excluded from participating in this trial if they meet any of the following criteria:
- •Obstructive intravesical median prostatic lobe or high bladder neck
- •Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- •Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
- •Elevated risk of prostate cancer
- •Post-void residual volume (PVR) > 250 ml
- •Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline
- •History of chronic urinary retention
- •History of neurogenic bladder
- •Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) due to bladder obstruction
- •Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test)
- •Concomitant bladder stones
- •Confirmed or suspected bladder cancer
- •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
- •Serious concurrent medical conditions such as uncontrolled diabetes
- •Known allergy to nickel
- •Life expectancy less than 24 months
- •Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
- •Patients taking coumadin 3 days or less prior to procedure and have INR value > 1.5 on day of procedure. ASA and clopidogrel must be ceased 7 days prior to the procedure
- •5 alpha reductase inhibitors within 6 months of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study)
- •alpha blockers within 2 weeks of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study)
- •Future fertility concerns
- •Any severe illness that might prevent study completion or would confound study results
结局指标
主要结局
Successful placement of the Zenflow Spring Implant
时间窗: Day of discharge up to 7 days following device placement
Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.
Need for urinary catheterization
时间窗: 7 days after the procedure
Rate of extended post-operative urinary catheterization
次要结局
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)(Baseline, 2 weeks, 1, 3, 6, 12, 24 months)
- Assessment of Sexual Health: Change in sexual health measured by change in ability to ejaculate using the Male Sexual Health Questionnaire - Ejaculatory domain (MSHQ-EjD)(Baseline, 3, 6, 12, & 24 months)
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient response to the International Prostate Symptom Score and Quality of Life Questionnaire (IPSS+QoL).(Baseline, 2 weeks, 1, 6, 12, 24 months)
- Repeat interventions to treat Benign Prostatic Hyperplasia (BPH)(Up to 2 years)
- Assessment of Sexual Health: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score(Baseline, 3, 6, 12, & 24 months)
- Incidence of procedure or device related serious adverse events(Day of discharge up to 7 days following device placement)
- Assessment of Pain(Baseline, 2 weeks, 1 month and 3 months)
- Assessment of Adverse Events(Up to 2 years)
- Increase or change in medications to treat Benign Prostatic Hyperplasia (BPH)(Up to 2 years)