At a glance
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3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia
In Brief
A clinical study evaluating 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH for Prostate Hyperplasia. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).
Study Details
Timeline
Arms & Interventions
Interventions
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.