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BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

NCT05443451 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-06

No results posted yet for this study

Summary

This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).

Conditions

  • Prostate Hyperplasia

Interventions

DEVICE

3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

The procedure will consist of a focal, transperineal, targeted microwave ablation of prostate adenoma. Surgical planning using 3D transrectal ultrasound and real-time monitoring of the ablation would preserve key anatomical landmarks such as the bladder neck, prostatic urethra and verumontanum. The Organ-Based Tracking (OBT®) patented technology would provide a 3D prostate model to facilitate real-time navigation-guided ablation and accurate mapping of treatment zone. The procedure will be conducted under general anaesthesia, spinal anaesthesia, or monitored anaesthetic care / sedation. An average number of one to three microwave ablations per lobe is expected, depending on the size and shape of each prostate. The microwave ablation parameters will be chosen intraoperatively. A urinary catheter may be necessary immediately after the procedure. Patients are planned to be discharged on the same day or the day after when they are fit for discharge.

Sponsors & Collaborators

  • Koelis

    collaborator INDUSTRY

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Peter Ka-Fung CHIU, FRCS, PhD · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Hong Kong

Study Locations

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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 NCT05443451 on ClinicalTrials.gov