Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.
2026년 8월 27일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
110
단계
단계
- 4단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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:
- Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment
- 5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment
- 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:
- Multiple sclerosis
- Parkinson's disease
- Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
The Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician.
|
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활성 비교기: 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.
|
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
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
International Prostate Symptom Score (IPSS) Total Score
기간: 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.
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Baseline (Day 1) to 3 months
|
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Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
기간: Baseline through study completion, an average of 1 year (Duration of study)
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Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
|
Baseline through study completion, an average of 1 year (Duration of study)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months
기간: 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
기간: 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
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Baseline 1, 3, 6 and 12 months
|
|
Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations
기간: Baseline through study completion, an average of 1 year (Study duration)
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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)
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The observed rates of device related AEs or Tamsulosin-related adverse events
기간: 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)
|
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연구 기록 날짜
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연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 9월 1일
기본 완료 (추정된)
기본 완료
2028년 9월 1일
연구 완료 (추정된)
연구 완료
2029년 9월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 19일
QC 기준을 충족하는 최초 제출
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처음 게시됨 (실제)
처음 게시됨
2026년 9월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
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2026년 8월 27일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CLIN-0298
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
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예
미국 FDA 규제 기기 제품 연구
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아니
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