Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Urotronic Inc.
Study ID
NCT06312722
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Optilume® BPH Catheter System — DEVICE
    The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.

Study Details

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Key Dates

First listed
Mar 15, 2024
Start date
Feb 7, 2024
Status verified
Jul 2026
Primary completion
Feb 7, 2031
Completion
Feb 7, 2031

Study Design

Enrollment
92 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Study Arm
    Optilume BPH Catheter System

Primary Outcome Measure

Change in International Prostate Symptom Score (IPSS) [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Arkansas UrologyLittle RockArkansas72211
Katie O'Brien
[email protected]
501-830-8050
Jeffrey Marotte, MD (PRINCIPAL_INVESTIGATOR)
Florida Urology Partners, LLPTampaFlorida33615
Linda Seibert
[email protected]
239-223-4488
Osvaldo Padron, MD (PRINCIPAL_INVESTIGATOR)
Ochsner LSU Health Shreveport - Regional UrologyShreveportLouisiana71106
Kayla Telano
[email protected]
318-383-4319
Jared Moss, MD (PRINCIPAL_INVESTIGATOR)
Sheldon Freedman MD, LtdLas VegasNevada89144
Danielle Freedman
[email protected]
702-732-0282
Sheldon Freedman, MD (PRINCIPAL_INVESTIGATOR)
Oregon Urology InstituteSpringfieldOregon97477
Maxim DiMarco
[email protected]
541-284-5508
David DiMarco, MD (PRINCIPAL_INVESTIGATOR)
Midtown Urology AssociatesAustinTexas78705
Andrew Barger, APRN
[email protected]
512-451-7935
Michael Trotter, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist Urology AssociatesHoustonTexas77030
Miguel Valdivia Y Alvarado
[email protected]
713-441-6455
Ricardo Gonzalez, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By research site
Arkansas Urology· Little Rock, ARFlorida Urology Partners, LLP· Tampa, FLOchsner LSU Health Shreveport - Regional Urology· Shreveport, LASheldon Freedman MD, Ltd· Las Vegas, NVOregon Urology Institute· Springfield, ORMidtown Urology Associates· Austin, TX

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