Initial Clinical Trials with a Tubless Lithotriptor

Abstract

The Medstone 1050 is a new tubeless lithotriptor developed in the United States. Under Food and Drug Administration guidelines a human treatment protocol has been developed. The first 50 patients treated at a single site and followed for a minimum of 3 months are presented. All stones treated were 3 cm. or less in longest dimension and located in the renal pelvis, calices or proximal ureter. An adequate fragmentation rate of 90% was achieved in this group. There were no significant complications in any patient. A larger multicenter study presently is underway.