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

NCT07194187 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-09

No results posted yet for this study

Summary

Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH).

The primary objective of the study is to determine the efficacy of HIFU therapy by assessing the changes in IPSS score in 6-month post HIFU procedure for BPH with compared to baseline.

The secondary objectives of this study are as follow:

* To assess any adverse events related to the procedure or device.
* To assess the operation related characteristics including: total operation time and ablation time required in HIFU procedure for BPH, total catheterization time after the HIFU procedure for BPH, and categorical ablation zone
* To assess the patient's post operative pain level at different post op time points.
* To assess the urinary flow and symptoms improvement by studying the changes in IPSS, Qmax, and PVR at different post op time points compared to the baseline.
* To assess the effectiveness of HIFU by studying the changes in PSA levels, types of medication for BPH or any urologic condition, proportion of patients who are taking BPH medication, prostate volume, and prostate calcification level and the reoperation rate within 12-month post-op.
* To assess changes in patients' sexual function at different post op time points.

The hypothesis is that a HIFU ablation is a safe and effective treatment for patients with LUTS due to BOO from BPH.

Conditions

  • Bladder Outlet Obstruction
  • BPH

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.

Sponsors & Collaborators

Principal Investigators

  • Michael Palese, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-09-20
Completion
2027-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194187 on ClinicalTrials.gov