High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction

NANot yet recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 17, 2025

Primary Completion Date

September 20, 2027

Study Completion Date

September 20, 2027

Conditions
Bladder Outlet ObstructionBPH
Interventions
DEVICE

High Intensity Focused Ultrasound

High Intensity Focused Ultrasound (HIFU) works with an image-guided transrectal probe that utilizes 3-10 MHz ultrasound waves at very high powers (200W). These waves can be very precisely directed at target tissue. Through both thermal and mechanical forces (shearing motion and mechanical energy leading to hyperthermia) the focal point core temperature can be raised significantly (\> 80°C) leading to coagulative necrosis to the target tissue while sparing surrounding tissue. The degree of tissue injury is based on the temperature and the duration of exposure, with the cooling off time allowing for the heat to dissipate to prevent the damage to surrounding tissues. The most common device involves a transrectal transducer with ultrasound guidance that can be performed under either general or spinal anesthesia. The device has been FDA approved to be used in ablation of prostatic tissue since 2018.

Trial Locations (1)

10003

Mount Sinai Union Square, New York

All Listed Sponsors
lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT07194187 - High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction | Biotech Hunter | Biotech Hunter