Zenflow Spring System in everyday use for enlarged prostate
Official title: Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
Run by Zenflow, Inc. · NCT07538622 · Data updated 2026-11-12
This registry tests how the Zenflow Spring System works for men with BPH in routine clinical settings and follows patients for 12 months after implantation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | Zenflow, Inc. Industry-sponsored |
| Locations | 8 sites (Phoenix, Arizona and 7 other locations) |
| Status | Recruiting |
| Started | July 29, 2026 |
| Main results expected | July 2028 |
| Study ends | September 2028 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07538622 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with symptomatic BPH who are treated with the Zenflow Spring System according to the device’s approved instructions for use.
✕Probably not a fit
Patients may not experience symptom relief or may encounter adverse events related to the device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, post-market registry evaluating the Zenflow Spring System for treating lower urinary tract symptoms due to BPH. It collects real-world data during the implant procedure and at 1, 3, 6, and 12 months of follow-up to assess symptom changes, return to daily activities, patient satisfaction, and any device-related problems or side effects. The study observes how the device performs in typical clinical practice across participating sites. It does not randomize patients or compare with another treatment as part of its design. The emphasis is on safety, usability, and practical outcomes in routine care.
Why it matters
Potential benefit: If successful, the registry could confirm real‑world safety and practicality of the Zenflow Spring System and demonstrate its impact on LUTS symptoms and patient quality of life.
How similar studies have gone: Post-market registries for similar minimally invasive devices have provided useful real-world safety and performance data, though results can vary by setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use Exclusion Criteria: * Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Where it's running
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San Diego Clinical Trials
La Mesa, California, United States Recruiting -
Gulf Coast Clinical Trial Associates / Florida Urology Partners
Tampa, Florida, United States Recruiting -
Avant Concierge Urology
Winter Garden, Florida, United States Recruiting -
The Smith Institute of Urology/Northwell Health
Syosset, New York, United States Recruiting -
Midtown Urology Associates
Austin, Texas, United States Recruiting -
Chopra Urology
Phoenix, Arizona, United States Not yet recruiting
Show 2 more locations
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Dr Slade Urology
Boise, Idaho, United States Active not recruiting -
START Research
Myrtle Beach, South Carolina, United States Active not recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.