The Zenflow Spring System Feasibility and Safety Study (ZEST)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Device Success defined as both 1) deliverability of the implant and 2) freedom from unanticipated adverse events (UAEs) not listed in the protocol or AEs that meet the protocol definition of Serious AEs.
研究概览
简要总结
This is a First in Human study to assess the feasibility, safety and effectiveness 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 is to evaluate the feasibility and safety of a novel prostatic urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). Effectiveness will also be measured. 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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •50 to 80 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
- •Anterior prostatic urethral length 2.5 - 4.0 cm by cystoscopy, as measured from bladder neck to verumontanum. TRUS will be accepted as a primary screening measure.
- •Failed or intolerant to medication regimen for the treatment of LUTS.
排除标准
- •New Zealand only: A maximum of 5 participants in acute or chronic urinary retention may be included in the study provided they meet other entry criteria. Exclusion exemptions for these patients are described in 4a, 5a and they are exempt from #
- •Participants will be excluded from participating in this trial if they meet any of the following criteria:
- •Obstructive median prostatic lobe or high bladder neck
- •Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- •Elevated Prostate Specific Antigen (PSA) (age 50-70 PSA ≥4; age 70+ PSA ≥6.5) unless negative biopsy within last 3 months, or a positive biopsy
- •Post-void residual volume (PVR) > 250 ml, if not in acute retention 4a. No maximum post void residual volume required if patient in acute or chronic urinary retention. (New Zealand Only, up to 5 patients)
- •Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline. 5a. No maximum urinary flow or minimum voided volume required if participant in acute or chronic urinary retention. (New Zealand Only, up to 5 patients)
- •History of chronic urinary retention. (New Zealand Only, up to 5 patients)
- •History of neurogenic bladder
- •Compromised renal function (e.g., serum creatinine > 1.8 mg/dl)
- •Concomitant Urinary Tract Infection (UTI)
- •Concomitant bladder stones
- •Confirmed or suspected prostate/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 12 months
- •Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
- •Anti-coagulant, anti-platelet, or thrombolytic medication other than Acetylsalicylic Acid (ASA) or Clopidogrel. ASA and Clopidogrel must be ceased 7 days prior to the procedure.
- •5--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).
- •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
研究组 & 干预措施
Treatment Group
Receives intervention with the Zenflow Spring System.
干预措施: Zenflow Spring System (Device)
结局指标
主要结局
Device Success defined as both 1) deliverability of the implant and 2) freedom from unanticipated adverse events (UAEs) not listed in the protocol or AEs that meet the protocol definition of Serious AEs.
时间窗: Intraoperative
Frequency of Device Success is assessed by subject, for both successful device placement in the target anatomy and absence of serious or unanticipated adverse events through discharge.
Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer
时间窗: Intraoperative
Frequency and severity of any device or procedure related adverse events, by subject.
Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis
时间窗: Seven days following implantation of the investigational device
Frequency of indwelling catheterization = or \> 7 days following placement of the investigational device.
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
时间窗: 3 months following device placement
Subjects should demonstrate improvement of \> or = to 3 point reduction from baseline measurement.
次要结局
- Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire(6 months, 12-,24-,36-, months post implantation)
- Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire(2 weeks, 1 month, 3 months)
- Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire(through 3 month follow-up)
- Improvement in Uroflowmetry compared to baseline(3-, 6-, 12-, 24-, 36-months post implantation)
- Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)(12 months 24 months and 36 months)
- Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH.(12 months 24 months and 36 months)