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ACTIVE NOT RECRUITING NA

Safety and Effectiveness Study of the Zenflow Spring System

NCT04987138 · View on ClinicalTrials.gov ↗

Study Summary

Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.

Interventions

  • DEVICE Sham Procedure
  • DEVICE Zenflow Spring System

Study Locations (7)

Texas

  • Midtown Urology Associates — Austin
  • Urology Austin, PLLC — Austin

California

  • American Institute of Research — Los Angeles

Illinois

  • Northshore University Health System — Glenview

Nevada

  • Sheldon Freedman, MD, LTD — Las Vegas

South Carolina

  • Carolina Urologic Research Associates — Myrtle Beach

Virginia

  • Urology of Virginia, PLLC — Virginia Beach

Trial Details

FieldValue
Enrollment Target 279 participants
Start Date 2021-09-30
Est. Completion 2026-06
Phase NA

Sponsor

Zenflow

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04987138

The ClinicalTrials.gov registry entry for NCT04987138 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zenflow, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with BPH (Benign Prostatic Hyperplasia) appearing as the primary indexed condition, and to 2 interventions — of which Sham Procedure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04987138 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Texas, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04987138 about?

NCT04987138 is a clinical study titled "Safety and Effectiveness Study of the Zenflow Spring System". Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.

What is the current status of trial NCT04987138?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 279 participants. The study started on 2021-09-30. Estimated completion is 2026-06.

What conditions does trial NCT04987138 study?

This clinical trial studies the following conditions: BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04987138?

The interventions under investigation include: Sham Procedure (DEVICE), Zenflow Spring System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04987138?

This trial is sponsored by Zenflow, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04987138 being conducted?

This trial has 7 study locations across California, Illinois, Nevada, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial