First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies

Area of Science:

• Urology
• Medical Technology
• Nephrology

Background:

• Urinary stone disease remains a significant clinical challenge.
• Current lithotripsy methods have limitations.
• Novel technologies are needed for effective stone comminution.

Purpose of the Study:

• To evaluate the first-in-human effectiveness and tolerability of burst-wave lithotripsy (BWL) for urinary stone comminution.
• To assess BWL's performance in different clinical settings.

Main Methods:

• An investigational BWL and ultrasonic propulsion system was employed.
• Participant A: A 7-mm kidney stone was targeted in the operating room prior to ureteroscopy.
• Participant B: A 7.5-mm ureterovesical junction stone was targeted in clinic without anesthesia.

Main Results:

• BWL successfully comminuted the renal stone (<2 mm fragments) in under 10 minutes for Participant A.
• Participant B tolerated BWL without pain or anesthesia and passed the ureterovesical junction stone on day 15.
• The technology demonstrated effectiveness in stone fragmentation and good patient tolerability.

Conclusions:

• First-in-human trials indicate BWL is effective for renal stone comminution.
• BWL shows promise for tolerability in awake patients with distal ureteral stones.
• This novel technology warrants further investigation for urinary stone treatment.