Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 19, 2017

Primary Completion Date

June 4, 2019

Study Completion Date

May 25, 2024

Conditions
Benign Prostatic HyperplasiaBenign Prostatic Hypertrophy
Interventions
DEVICE

Optilume™ BPH Prostatic DCB Dilation Catheter

BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

DRUG

Paclitaxel

paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

Trial Locations (5)

Unknown

Union Medica Hospital, Santiago de los Caballeros

Urolaser SRL, Santo Domingo Oeste

Centro Medico Dr. Canela, SRL, La Romana

Consultorios Royal Center, Panama City

Centro Especializado San Fernando, Panama City

All Listed Sponsors
lead

Urotronic Inc.

INDUSTRY

NCT03423979 - Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter | Biotech Hunter | Biotech Hunter