BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

NARecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 8, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

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.

Trial Locations (1)

Unknown

RECRUITING

Prince of Wales Hospital, Hong Kong

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Koelis

INDUSTRY

lead

Chinese University of Hong Kong

OTHER

NCT05443451 - BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY | Biotech Hunter | Biotech Hunter