Clinical trials of the Northgate SD-3 dual-purpose lithotriptor for renal calculi.

Abstract

The Northgate SD-3 is a bathless, portable shock wave lithotriptor made in the United States. It uses ultrasound localization and spark-gap, electrode-generated shock waves to fragment calculi in the upper urinary tract. Since October 1987, 312 treatments have been performed on 281 patients (286 kidneys) with stone burdens less than 2 cm. during clinical trials at 6 investigational sites in the United States. A fragmentation rate of 94% was achieved. Of the treatments 78% were judged successful (stone-free or fragments of less than 5 mm. remaining in an asymptomatic patient) and a 3-month stone-free rate of 58% was noted. The retreatment rate was 9% and the ancillary procedure rate was 5%. The complications (hematuria, ecchymosis, pain, obstruction) were mild and not unlike those seen in patients undergoing lithotripsy with other devices.

Cite this paper

@article{Swanson1992ClinicalTO, title={Clinical trials of the Northgate SD-3 dual-purpose lithotriptor for renal calculi.}, author={Scott K Swanson and Thayne R. Larson and Frank P Begun and Donald L. Lamm and Eugene F. Fuchs and Jon L Hyman and Jeffry L. Huffman}, journal={The Journal of urology}, year={1992}, volume={148 3 Pt 2}, pages={1047-51} }