NCT05443451

BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a prospective, single centre, open-label and non-comparative trial planned on 12 patients. Patients who fit inclusion criteria would be recruited and offered microwave ablation to the enlarged prostate. The patients will be closely followed up to 6 months after treatment with serial assessment on safety and efficacy.

Conditions

• Prostate Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-08
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2022-07-05
• Last updated: 2025-05-06

Locations

1 site across 1 country: Hong Kong