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To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate. (REBOUND)

2026年11月10日 更新者：ALPFA Medical

A Prospective Randomized Pivotal Trial of the ALPFA Medical Prostate Ablation System Compared With Cystoscopy in Men With Symptomatic Benign Prostatic Hyperplasia

The main goal of this study is to evaluate the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System for treatment of enlarged prostate (BPH) symptoms. The study will involve up to 250 male participants who have urinary problems caused by BPH and whom are greater than 40 years of age in up to 30 investigational centers across the US,Canada and European Union.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This study aims to test how safe and effective the ALPFA BPH PFA System is for treating men over age 40 who have urinary problems caused by an enlarged prostate (BPH).The study will involve up to 250 participants in up to 30 investigational centers across the US, Canada, and European Union.

Men who agree to join the study will have health checks before treatment. Those who meet the study eligibility criteria including medication washout requirements,will be placed by chance into one of two groups. Two out of three men will receive treatment with the ALPFA BPH PFA System. One out of three men will receive a sham procedure that looks like treatment but does not deliver treatment.Participants will be followed for longer term safety and effectiveness for a total of 5 years post treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System.

Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit.

After 3 months, participants will be told which group they were in. Men who were in the sham group may choose to receive treatment with the ALPFA BPH PFA System. Men in the sham group who do not choose treatment by 6 months will no longer take part in the study.

All men who receive treatment will have follow-up visits at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months. After that, they will be checked once a year for up to 5 years.

研究类型

介入性

注册 (估计的)

250

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Arizona
      • Mesa、Arizona、美国、85206
      • Sun City、Arizona、美国、85351
        • 招聘中
        • Academic Urology & Urogynecology of Arizona
      • Tucson、Arizona、美国、85712
        • 尚未招聘
        • Del Sol Research Management
    • California
      • Bakersfield、California、美国、93301
      • La Mesa、California、美国、91942
        • 招聘中
        • San Diego Clinical Trials
        • 接触：
          • Brian
      • Sacramento、California、美国、95823
    • Colorado
      • Lone Tree、Colorado、美国、80124
        • 招聘中
        • Urology Associates - Lone Tree
        • 接触：
        • 首席研究员：
          • James Fagelson
    • Florida
      • Tampa、Florida、美国、33619
        • 招聘中
        • Gulf Coast Clinical Trial Associates
        • 接触：
          • Jodi
      • Winter Garden、Florida、美国、34788
    • Idaho
      • Meridian、Idaho、美国、83642
        • 招聘中
        • Capital Surgical Associates
        • 接触：
        • 首席研究员：
          • Austen Slade
    • Illinois
      • Lake Barrington、Illinois、美国、60010
        • 招聘中
        • Comprehensive Urology
        • 接触：
        • 首席研究员：
          • Ning Wu
    • Louisiana
      • Lafayette、Louisiana、美国、70508
    • Nebraska
      • Kearney、Nebraska、美国、68847
        • 招聘中
        • Kearney Urology Center
        • 接触：
          • Monique
    • New York
      • Plainview、New York、美国、11803
        • 招聘中
        • The Smith Institute of Urology Northwell Health
        • 接触：
          • Jennifer
    • Tennessee
    • Texas
      • Austin、Texas、美国、78705
      • San Antonio、Texas、美国、78240
        • 招聘中
        • The Urology Place
        • 接触：
        • 首席研究员：
          • Naveen Kella
      • West Lake Hills、Texas、美国、78746
        • 招聘中
        • Midtown Urology Associates
        • 接触：
          • Andrew

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria: Study subjects are required to meet all the following inclusion criteria to participate in this study as determined by the Investigator:

  1. ≥ 45 years of age on the day of enrollment.

  2. Symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s):

    1. Symptom Score: Baseline IPSS score ≥13
    2. Flow Rate: Uroflow test with a pre-void bladder volume ≥150 mL (confirmed by bladder scan),Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec and ≤ 15 mL/s
    3. Residual: ultrasound-determined PVR of ≤ 250 mL

  3. Prostate size 25-150 g, measured by transrectal ultrasound.

  4. Willing and able to provide consent and comply with study requirements.

Exclusion Criteria:Subjects will be excluded from the study if they meet any one of the following exclusion criteria, as determined by the Investigator:

  1. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:

    1. Cardiovascular:

      • History of clinically significant heart failure (NYHA III/IV)
      • Uncontrolled arrhythmia.
      • Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, or any cardiac surgery within 180 days of enrollment.
      • Uncontrolled hypertension (> 160 mmHg systolic or > 95 mmHg diastolic on repeat measurements)

    2. Renal: Serum creatinine > 2.0 mg/dL or any history of renal dialysis or renal transplant.

    3. Metabolic: Clinically uncontrolled diabetes mellitus or a baseline HbA1c ≥ 8.0%, or clinically significant liver disease.

    4. Non-urologic cancer: Active malignancy, or within 3 years of enrollment, a history of treated malignancy now in full remission, except basal cell or squamous cell carcinoma of the skin.

    5. Respiratory: Severe lung disease or respiratory illness requiring hospitalization.

    6. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication, or current chemotherapy.

    7. Transplant: Solid organ or hematologic transplant or currently being evaluated for an organ transplant.

    8. Substance abuse: Active alcoholism or drug addiction.

    9. Sleep apnea: Known moderate to severe obstructive sleep apnea that is untreated or therapy non-compliant

  2. Urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:

    1. Operative: Previous prostate surgery or interventional procedure, including but not limited to BPH surgery, radiation, laser, prostate arterial embolism, balloon dilatation, or hyperthermic treatment, or prostate biopsy within 40 days of the Index Procedure.
    2. Infection: Urinary tract infection (UTI) (105 CFU/mL) within 90 days of enrollment or >3 UTIs within the year prior to enrollment.
    3. Incontinence: History of urinary incontinence.
    4. Retention: Requires indwelling catheter or intermittent catheterization to void or had an episode of spontaneous urinary retention within 30 days of enrollment.
    5. Prostatitis: History of prostatitis or chronic pelvic pain syndrome (CPPS) within 2 years of enrollment.
    6. Cystolithiasis: Active bladder stones
    7. Neurogenic bladder: Neurogenic or atonic bladder or sphincter, including etiologies of uncontrolled diabetes, Parkinson's disease, multiple sclerosis, cerebrovascular accident, or polyneuropathy.
    8. Anatomic abnormality: Prior or current urethral stricture, meatal stenosis, bladder neck contracture, or other urologic anatomic abnormalities that would interfere with planned treatment or confound subsequent assessment.
    9. Implants: Any urinary tract implants including stents, sutures, penile implants, or artificial sphincters.
    10. Hematuria: Hematuria without a known contributing factor within 90 days of the Index Procedure.

  3. Bladder cancer: Actively being treated or suspected cancer of the bladder.

  4. Prostate cancer:

    1. Confirmed or history of prostate cancer
    2. Baseline PSA > 15 ng/mL within 30 days of enrollment
    3. If PSA is between 4.0 ng/mL and 15 ng/mL, prostate cancer must be ruled out with a negative biopsy or an MRI (≤PIRADS-3) within 12 months prior to enrollment.

  5. Prior pelvic or rectal interventions:

    1. Previous pelvic irradiation or radical pelvic surgery
    2. Previous rectal surgery (other than hemorrhoidectomy) or a history of rectal disease that may be impacted by Index Procedure.

  6. Peri-procedural anticoagulation: Unable to stop anti-platelet or anticoagulation treatment for the Index Procedure per site standard of care.

  7. Subjects who cannot or will not comply with the following washout medication requirements within the time period specified prior to enrollment:

    1. 24-Hours:

      • i. Taking phenylephrine or pseudoephedrine within 24 hours of the Baseline evaluation and Index Procedure.

    2. 1 Week:

      • i. Antihistamine, anticonvulsant, or antispasmodics medications within 1 week of enrollment unless documented on a stable (unchanged) dose for 180 days prior to enrollment.

    3. 2 Weeks:

      • i. Use of alpha blockers or daily dosage of PDE5 inhibitors (tadalafil [Cialis]) for BPH within 2 weeks prior to enrollment.
      • ii. Use of anticholinergics or beta-3 adrenergic receptor agonists (e.g., mirabegron, vibegron) within 2 weeks prior to enrollment, unless documented on a stable dose for 30 days prior to enrollment.

    4. 3 Months:

      • i. Taking estrogen, drugs producing androgen suppression, or androgens within 90 days prior to enrollment, unless documented on a stable dosage for at least 180 days prior to enrollment.
      • ii. Use of Type II 5-alpha reductase inhibitor medication (e.g., finasteride [Proscar, Propecia]) within 90 days of enrollment OR anticipated use within the first 12 months of follow-up.

    5. 6 Months:

      • i. Use of any Type I 5-alpha reductase inhibitor medication (e.g., dutasteride [Avodart]) within 180 days prior to enrollment OR anticipate use within the first 12 months of follow-up.
      • ii. Taking tricyclic antidepressants that are not on a stable dose for the 180 days prior to enrollment OR anticipate stopping or changing treatment in the first 12 months of follow-up.

  8. Subjects who wish to maintain their fertility.

  9. Current or anticipated enrollment in any other randomized or interventional clinical study (registry or retrospective studies permitted).

  10. Vulnerable populations, including individuals who are incarcerated or institutionalized.Any physical, psychological, or developmental impairment (e.g., developmental delay) that, in the investigator's opinion, would compromise the subject's ability to provide informed consent, comply with study procedures, or complete patient-reported outcome measures.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Treatment Device

Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a treatment group and treated with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study
设备：Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System

After the participant receives anesthesia, the Investigator will proceed with placement of the ALPFA GRAIL PFA Catheter into the prostate via a standard flexible cystoscope. Visualization of the prostatic urethra will determine the number of balloons that are exposed and inflated.

When the catheter has been properly positioned, the ALPFA GRAIL PFA Console will be activated and one PFA application will be delivered. The Investigator will assess if the catheter needs to be repositioned and additional ablation applications delivered, as necessary. Once ablation is complete, the catheter balloons will be deflated, and the catheter will be withdrawn from the urethra.

Participants will then have follow-up visits with health checks as planned for this study.
假比较器：Control Device

Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a control group and treated with sham flexible cystoscopy (Control) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study
设备：Control Device: Sham flexible cystoscopy

Participants will receive mock treatment with a flexible cystoscope with a working channel that is at least 6.9F in diameter. The cystoscope will be inserted and treatment script initiated. Once the script is completed, the cystoscope will be removed and procedural details captured on the relevant CRF.

Participants will then have follow-up visits with health checks as planned for this study.
其他：Crossover Cohort

Control Arm (Sham) patients can receive treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System after their 3-month follow-up assessments are completed, and participant symptom profile necessaites treatment and alll protocol defined enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment)Unless treated with the ALPFA GRAIL™ Pulsed Field Ablation(PFA)System, the subject will be exited from the study once they have completed their 3-month follow-up visit.
设备：Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System

After the participant receives anesthesia, the Investigator will proceed with placement of the ALPFA GRAIL PFA Catheter into the prostate via a standard flexible cystoscope. Visualization of the prostatic urethra will determine the number of balloons that are exposed and inflated.

When the catheter has been properly positioned, the ALPFA GRAIL PFA Console will be activated and one PFA application will be delivered. The Investigator will assess if the catheter needs to be repositioned and additional ablation applications delivered, as necessary. Once ablation is complete, the catheter balloons will be deflated, and the catheter will be withdrawn from the urethra.

Participants will then have follow-up visits with health checks as planned for this study.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Safety-Incidence of Serious Device-or Procedure-Related Adverse Events (Composite Safety Endpoint)
大体时间：Through 12 months post-procedure

The primary safety endpoint is the proportion of participants experiencing one or more of the following serious device-related or procedure-related adverse event through 12 months post-procedure
Through 12 months post-procedure
Effectiveness-Change from Baseline in International Prostate Symptom Score (IPSS) at 3 Months.
大体时间：Baseline to 3 months post-procedure

The International Prostate Symptom Score (IPSS) is a 7-item questionnaire (score range 0-35) where higher scores indicate more severe symptoms. Success is defined as the Treatment group showing a 25% greater relative improvement in mean score compared to the Control group
Baseline to 3 months post-procedure
Effectiveness-Durability of Treatment Effect: Percent Change in International Prostate Symptom Score (IPSS) at 12 Months
大体时间：Baseline to 12 months post-procedure

This endpoint evaluates the long-term effectiveness of the ALPFA GRAIL PFA System. It is calculated as the mean percentage change in the total International Prostate Symptom Score (IPSS) score from the start of the study (baseline) to the 12-month follow-up for participants in the treatment group.
Baseline to 12 months post-procedure

次要结果测量

结果测量
措施说明
大体时间
Additional Study Goals
大体时间：3 months

1.Comparison of Symptom Improvement (at 3 Months) Researchers will compare the average change in prostate symptoms between the group that received the study treatment and the control group. This helps show if the treatment provides more relief than the standard comparison.
3 months
Success Stories (Responder Rate)
大体时间：3 months

2. Number of "Success Stories" (Responder Rate) The study will count how many participants had a meaningful improvement in their symptoms. A "responder" (a success) is defined as a person whose symptoms improved by at least 30% three months after the treatment.
3 months
Improvement in Urine Flow
大体时间：3 months

3. Improvement in Urine Flow (Qmax) Researchers will measure the strength of the participant's urine flow. They will compare the average change in flow strength from the start of the study to three months later between the treatment group and the control group.
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ALPFA Medical

调查人员

  • 首席研究员：Dr. Bilal Chughtai、The Smith Institute of Urology/Northwell Health
  • 首席研究员：Dr. Dean Elterman、University Health Network, Toronto

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月28日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2032年12月1日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年5月11日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CS00004

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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