The first participants have been enrolled in a clinical trial to test focused ultrasound histotripsy for the treatment of symptomatic benign prostatic hyperplasia (BPH).
The research study, called WOLVERINE, is exploring the safety and feasibility of using the HistoSonics Edison histotripsy system to treat symptomatic BPH. The first of 20 participants were enrolled at Prince of Wales Hospital in Hong Kong by Peter Chiu. Additional sites are expected to join the trial.
Participants will undergo a single histotripsy procedure to target and destroy the enlarged prostate tissue and complete imaging within 72 hours of the procedure to assess the immediate treatment effect. Researchers will then follow participants for at least six months to further evaluate safety and procedural outcomes.
“BPH affects millions of men worldwide and most of the existing treatment options require invasive procedures or lengthy recovery times,” said HistoSonics chairman and chief executive officer Mike Blue. “We believe histotripsy’s ability to mechanically destroy targeted tissue, completely noninvasively, has the potential to transform how BPH is treated. In addition, this milestone represents significant progress in our pursuit to expand the unique benefits of histotripsy over a significant number of serious clinical conditions throughout the body.”
The Edison platform is an image-guided, sonic beam therapy system that employs histotripsy to noninvasively and mechanically destroy targeted tissue. It has gained UK approval and US Food and Drug Administration (FDA) clearance to treat liver tumours, and it is also being tested to treat kidney tumours and pancreatic cancer.
