Optilume™ BPH Catheter System in Men With Symptomatic BPH
Public ClinicalTrials.gov record NCT04131907. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)
Study identification
- NCT ID
- NCT04131907
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 162 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 80 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 5, 2020 (Actual)
- Primary completion
- Aug 23, 2022 (Actual)
- Completion
- May 2027 (Estimated)
- Last update posted
- Jul 30, 2026
2020 – 2027
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| Colorado Clinical Research | Golden | Colorado | 80401 | — |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | — |
| Florida Urology Partners | Tampa | Florida | 33615 | — |
| Comprehensive Urologic Care | Lake Barrington | Illinois | 60010 | — |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | — |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | — |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | — |
| Sheldon Freedman MD, Ltd | Las Vegas | Nevada | 89144 | — |
| New Jersey Urology | Englewood | New Jersey | 07631 | — |
| AccuMed Research Associates | Garden City | New York | 11530 | — |
| Manhattan Medical Research Practice, PLLC | New York | New York | 10016 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Associated Urologists of NC | Raleigh | North Carolina | 27612 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Urology Austin, PLLC | Austin | Texas | 78745 | — |
| North Austin Urology | Austin | Texas | 78750 | — |
| Rio Grande Urology | El Paso | Texas | 79912 | — |
| Clear Lake Specialties | Webster | Texas | 77598 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04131907, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04131907 live on ClinicalTrials.gov.