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Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.

2026年8月27日更新者：Zenflow, Inc.

Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH

This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS/BPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The purpose of this post-market clinical trial (PMCT) is to compare the Zenflow Spring System with Tamsulosin in men with moderate to severe BPH symptoms who are not currently receiving treatment.

The study will look at how well each treatment works, how long the results last, how quickly patients return to normal activities, how satisfied they are with their treatment, and any side effects. Patients will be followed at 1, 3, 6, and 12 months. The study will also track any implant removals or additional procedures, as well as any changes to or stopping of Tamsulosin.

Patients who qualify for the study will be randomly assigned, with an equal chance, to receive either the Zenflow Spring System or Tamsulosin.

Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria. No crossover will be permitted beyond 30 days after completion of the 12-month follow-up. Patients who elect crossover and have a successful placement of the Spring Implant will be followed for 1 additional month and then will exit the study.

研究类型

介入性

注册 (估计的)

110

阶段

第四阶段

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

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.

In addition to the above labeling requirements, patients must also meet all the following criteria to be eligible for enrollment in this study:

Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)
Not actively taking any medication indicated for BPH, defined as current use of:
1. Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment
2. 5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment
3. PDE5 daily use (on demand use is permitted)
Ability to provide informed consent and comply with study procedures and follow-up schedule

Exclusion Criteria:

Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)
Neurologic conditions affecting bladder function, including but not limited to:
1. Multiple sclerosis
2. Parkinson's disease
3. Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction

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：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Zenflow Arm: Zenflow Spring System Treatment Zenflow Arm: Patients randomized to the Zenflow Spring System arm will undergo the procedure according to manufacturer specifications and standardized procedural protocols.	设备：Zenflow Arm: Zenflow Spring System implant procedure The Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician.
有源比较器：Tamsulosin Treatment Medical Therapy Arm: Patients randomized to the medical therapy arm will receive Tamsulosin 0.4 mg once daily. Subjects will be encouraged to remain on this medical therapy through at least 3 months of treatment, unless significant adverse health reaction occurs.	药品：Medical Therapy Tamsulosin Tamsulosin is a prescription medicine that relaxes the muscles around the prostate and bladder to help men with an enlarged prostate (BPH) urinate more easily

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
International Prostate Symptom Score (IPSS) Total Score 大体时间：Baseline (Day 1) to 3 months	Mean change in IPSS Total Score from baseline at 3 months. This is a 7-question patient questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better.	Baseline (Day 1) to 3 months
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs). 大体时间：Baseline through study completion, an average of 1 year (Duration of study)	Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).	Baseline through study completion, an average of 1 year (Duration of study)

次要结果测量

结果测量	措施说明	大体时间
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months 大体时间：Baseline at 1, 6, and 12 months	Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months. This is a 7-question questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better	Baseline at 1, 6, and 12 months
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months 大体时间：Baseline 1, 3, 6 and 12 months	Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months. This separate Quality of Life (QoL) question, scored 0-6, is asking how the patient would feel if they had to live with their current urinary condition for the rest of their life. The QoL score is reported separately and is not included in the 0-35 IPSS total	Baseline 1, 3, 6 and 12 months
Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations 大体时间：Baseline through study completion, an average of 1 year (Study duration)	In the Spring Implant arm, the patient will be asked if they remain implanted with the Spring Implant and if since last visit, if patient initiated any concomitant BPH medication use (for > 2 weeks). In the Medical Therapy Arm the patient will be asked since last visit, to confirm if they have been consistently taking Tamsulosin at the required dose.	Baseline through study completion, an average of 1 year (Study duration)
The observed rates of device related AEs or Tamsulosin-related adverse events 大体时间：Baseline through study completion, an average of 1 year (Duration of study)	The observed rates of device related AEs or Tamsulosin-related adverse events	Baseline through study completion, an average of 1 year (Duration of study)

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

Zenflow, Inc.

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 (估计的)

2026年9月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2026年7月19日

首先提交符合 QC 标准的

2026年8月27日

首次发布 (实际的)

2026年9月1日

研究记录更新

最后更新发布 (实际的)

2026年9月1日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.