An observational study in BPH (Benign Prostatic Hyperplasia), sponsored by Zenflow, Inc.. Recruiting at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Zenflow, Inc. · Observational
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.
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.
Exclusion Criteria:
Minimally Invasive Treatment for LUTS associated with BPH
Effectiveness - IPSS
The primary effectiveness endpoint is the change in IPSS from baseline over time
Time frame: Baseline to 12 Months
Safety - adverse events
The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)
Time frame: Baseline to 12 Months
Plan to share: No
No publications or documents are linked to this record.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Zenflow, Inc.