Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
1 other identifier
observational
300
1 country
5
Brief Summary
The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2026
CompletedFirst Posted
Study publicly available on registry
April 20, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
July 21, 2026
July 1, 2026
2 years
April 13, 2026
July 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effectiveness - IPSS
The primary effectiveness endpoint is the change in IPSS from baseline over time
Baseline to 12 Months
Safety - adverse events
The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)
Baseline to 12 Months
Interventions
Minimally Invasive Treatment for LUTS associated with BPH
Eligibility 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.
You may qualify if:
- Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
You may not qualify if:
- Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zenflow, Inc.lead
Study Sites (5)
San Diego Clinical Trials
La Mesa, California, 91942, United States
Gulf Coast Clinical Trial Associates / Florida Urology Partners
Tampa, Florida, 33615, United States
Avant Concierge Urology
Winter Garden, Florida, 34787, United States
The Smith Institute of Urology/Northwell Health
Syosset, New York, 11791, United States
Midtown Urology Associates
Austin, Texas, 78705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2026
First Posted
April 20, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share