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Not yet recruiting NCT07538622

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

— Observational BPH (Benign Prostatic Hyperplasia)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zenflow Spring System.
Who it may be relevant to
Registry conditions: BPH (Benign Prostatic Hyperplasia). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Zenflow Spring System
    Minimally Invasive Treatment for LUTS associated with BPH

Primary outcome measures

  • Effectiveness - IPSS [Time frame: Baseline to 12 Months]
  • Safety - adverse events [Time frame: Baseline to 12 Months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 5 centers
  • San Diego Clinical Trials — La Mesa
  • Gulf Coast Clinical Trial Associates / Florida Urology Partners — Tampa
  • Avant Concierge Urology — Winter Garden
  • The Smith Institute of Urology/Northwell Health — Syosset
  • Midtown Urology Associates — Austin

Identifiers

NCT: NCT07538622 · CLIN-0297

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗