Clinical trials of the Northgate SD-3 dual-purpose lithotriptor for renal calculi.
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.
Swanson
S K
SK
Section of Urology, Mayo Clinic Scottsdale, Arizona 85259.
Larson
T R
TR
Begun
F P
FP
Lamm
D L
DL
Fuchs
E F
EF
Hyman
J
J
Huffman
J L
JL
D000328:Adult; D000368:Aged; D004867:Equipment Design; D005260:Female; D006801:Humans; D007669:Kidney Calculi / Q000628:therapy*; D008096:Lithotripsy / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction