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A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
NCT06849258 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
Conditions Studied
Interventions
- DEVICE FloStent
- DEVICE Sham (Control)
Study Locations (20)
California
- Michael G Oefelein Clinical Trials — Bakersfield
- Comprehensive Urology Medical Group — Beverly Hills
- Atlas Men's Health — La Mesa
- Urology Group of Southern California — Los Angeles
- Prestige Medical Group — Tustin
Texas
- Midtown Urology Associates — Austin
- Urology Austin/Urology America — Austin
- Houston Methodist — Houston
Illinois
- Duly Health — Lisle
- Loyola Medicine — Maywood
New York
- Manhattan Medical Research NYU Langone — New York
- Northwell Health — Syosset
Colorado
- Urology Denver — Littleton
Florida
- Advanced Urology Institute — Daytona Beach
Louisiana
- Southern Urology — Lafayette
Michigan
- Michigan Institute of Urology — Troy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2032-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06849258
The ClinicalTrials.gov registry entry for NCT06849258 describes a study currently listed as 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 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rivermark Medical, 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 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions — of which FloStent 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: NCT06849258 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Texas, 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 NCT06849258 about?
NCT06849258 is a clinical study titled "A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms". The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those random...
What is the current status of trial NCT06849258?
This trial is currently recruiting. It is a NA study. The enrollment target is 215 participants. The study started on 2025-02-10. Estimated completion is 2032-12-31.
What conditions does trial NCT06849258 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06849258?
The interventions under investigation include: FloStent (DEVICE), Sham (Control) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06849258?
This trial is sponsored by Rivermark Medical, 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 NCT06849258 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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