Presented by: Ehud Willenz DVM
Shamir Medical Center

Introduction

The trans-perineal (TP) approach to the prostate for Ultrasound (US) imaging and for focal therapy using High Intensity Focused Ultrasound (HIFU) offers several advantages over alternatives. TP US-guided HIFU could become a completely non-invasive treatment for Benign Prostatic Hyperplasia (BPH), in contrast to the existing minimally invasive ones.

We present the results of pre-clinical studies demonstrating US-guided HIFU ablation with real-time tracking of the focal point prior to and during the ablation process.

During pre-clinical phase of the TP US-guided HIFU ablation system, experimental treatment was suggested to dog owners for dogs diagnosed with prostate cancer. Prior to dog treatment, a safety in-vivo experiment was performed in a pig model.

Materials

NINA Medical’s (Nazareth, Israel) HIFU system was used for the ablation. The pre-clinical safety experiments were approved by local Helsinki committee 14/2020 (Shamir Medical Center) and experimental treatments for dogs were approved by local Helsinki committee MD-21-16565-3 (Hebrew University). Two treatment attempts were applied to two different dogs.

Figure depicts the HIFU beam visualization as was observed in-situ (pig's thigh) in real-time with schematic drawings of the system location. During sonication, a fused display of the anatomy and HIFU imaging is presented to the physician. (1) schematics of transducer location on the skin, (2) a water balloon coupled to the skin, (3) the skin interface, (4) real-time visualization of the focal point.

Results

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Four different lesions were created in pig’s thigh during the safety experiment, using various HIFU parameters, under US guidance.

During treatment, dogs were under general anesthesia, and the prostate was approached via the abdomen due to the lack of substantial perineum. The prostate capsule, the urethra (catheterized) and the HIFU beam were observed with US, including US imaging of the focal point within the prostate.

No skin burns or any damage to the surrounding tissue including the urethra was observed following the treatments.

Conclusion

New HIFU imaging technology provides real-time feedback from the focal point within the body prior to and during ablation, paving the way for TP non-invasive treatment of BPH.

Funding

NINA Medical Ltd.

Co-Authors

Gilad Segev, DVM
Hebrew University

Yoni Hertzberg, PHD
NINA Medical

Alex Volovick,
NINA Medical

Shmuel Ben-Ezra,
NINA Medical

Doron Kopelman, MD
Technion, Israel Institute of Technology