NCT06136819进行中（未招募）1 期
Safety and Feasibility Dose Escalation Study for Evaluation of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Absence of unanticipated adverse events (UAEs) not listed in the protocol or Adverse Events (AEs) that meet the protocol definition of Serious Adverse Events (SAEs)
研究概览
简要总结
RT-310, a novel implant, is intended to minimally invasive treat locally the prostate gland for the management of prostate disease, while minimizing side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.
详细描述
The RT-310 study is a first in human Phase 1 multi-center prospective, non-randomized dose escalation study to evaluate the safety and feasibility of RT-310 for treatment of Benign Prostatic Hyperplasia (BPH). Study participants will have placement of RT-310 and be followed through 180 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Male gender
- •Diagnosis of symptomatic BPH
- •Age ≥ 50 years up to 80 years
- •International Prostate Symptom Score (IPSS) ≥ 13
- •Prostate volume 30 to 80 cc per ultrasound
- •Inadequate response and/or refusal of medical therapy for LUTS
排除标准
- •Current urinary retention or at significant risk of urinary retention after drug washout
- •Have an obstructive or protruding median lobe of the prostate
- •Previous BPH surgical procedure or implants, urethral stricture, Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- •Previous pelvic surgery or irradiation
- •History of neurogenic or atonic bladder
- •Stress urinary incontinence, mixed or urge incontinence
- •History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
- •History of compromised renal function or upper urinary tract disease
- •Other co-morbidities that could impact the study results such as: severe cardiac arrhythmias uncontrolled by medications or pacemaker; congestive heart failure New York Heart Association (NYHA) III or IV; History of uncontrolled diabetes mellitus; significant respiratory disease in which hospitalization may be required
- •Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
- •No more than two documented active urinary tract infections (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
- •Current gross hematuria and/or visible hematuria with participant urine sample without known contributing factor
- •Presence of a penile implant or stent(s) in the urethra or prostate
- •PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
- •Sensitivity to RT-310
- •Unable to undergo magnetic resonance imaging (MRI) such as presence of cardiac pacemaker or implanted cardiac defibrillator
- •Parkinson's disease or other neurologic disease that may impact bladder function such as stroke, TIA, multiple sclerosis
结局指标
主要结局
Absence of unanticipated adverse events (UAEs) not listed in the protocol or Adverse Events (AEs) that meet the protocol definition of Serious Adverse Events (SAEs)
时间窗: Baseline to Day 180
Adverse events
次要结局
- Uroflowmetry measure of Qmax(Baseline to Day 180)
- Uroflowmetry measure of voided volume(Baseline to Day 180)
- Change in prostate volume(Baseline to Day 180)
- Uroflowmetry measure of Qave(Baseline to Day 180)
- Change in IPSS(Baseline to Day 180)
- PVR(Baseline to Day 180)
研究者
研究点 (7)
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