OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Part of paid clinical trials in Sacramento, California.

Sponsor
Urotronic Inc.
Study ID
NCT06560476
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Data collection — OTHER
    Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.

Study Details

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Key Dates

Start date
Mar 30, 2024
Status verified
Mar 2026
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Study Arm
    This is the data collection study arm. There is no other arm in the study.

Primary Outcome Measure

The primary efficacy endpoint is the average IPSS change from baseline to 12 months. [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Golden State UrologySacramentoCalifornia95823-
Florida Urology PartnersTampaFlorida33615
Jodi Mummert
[email protected]
813-431-4913
Alejandra Valdes
[email protected]
813-764-7147
Osvaldo Padron, MD (PRINCIPAL_INVESTIGATOR)
Alonso Alvarez, MD (SUB_INVESTIGATOR)
Stephanie Stillings, MD (SUB_INVESTIGATOR)
Kearney Urology CenterKearneyNebraska68847
Garrett Pohlman, MD
[email protected]
303-249-7570
Garrett Pohlman, MD (PRINCIPAL_INVESTIGATOR)
The Urology Center, P.C.OmahaNebraska68144-
Sheldon Freedman, LtdLas VegasNevada89144
Omar Darwish
[email protected]
702-732-0282
Danielle Freedman
[email protected]
7027320282
Sheldon Freedman, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health - Smith Institute of UrologySyossetNew York11791
Jennifer Polo
[email protected]
5167603980
Chughtai, MD (PRINCIPAL_INVESTIGATOR)
Good Samaritan HospitalCorvallisOregon97330-
Midtown UrologyAustinTexas78705
Andrew Barger
[email protected]
5124517935
Tyler McClintock, MD (PRINCIPAL_INVESTIGATOR)
Potomac UrologyWoodridgeVirginia22191-

Find similar trials in Sacramento, CA

By research site
Golden State Urology· Sacramento, CAFlorida Urology Partners· Tampa, FLKearney Urology Center· Kearney, NEThe Urology Center, P.C.· Omaha, NESheldon Freedman, Ltd· Las Vegas, NVNorthwell Health - Smith Institute of Urology· Syosset, NY

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