title: [Clinical safety and efficacy of a novel intracorporeal combined pneumatic and ultrasonic lithotriptor (CQS-01) compared with Swiss LithoClast Master (EMS-III)].
abstract: OBJECTIVE
  To evaluate the safety and efficacy of a new intracorporeal pneumatic and ultrasonic lithotriptor (CQS-01).
  
  
  METHODS
  Eighty-six patients with renal or upper ureteral stones suitable for percutaneous nephrolithotomy (PNL) treatment were randomly divided into trial group (treated with CQS-01 device) and control group (treated with EMS-III device), with 43 patients in either group respectively. All the patients were followed up for 7 ± 3 days post-operation. The data were collected and analyzed with regard to stone burden, postoperative stone clearance rate, operation time, stone fragmentation and extraction time, volume of extracted stones, changes of red blood cells (RBC) and hemoglobin (Hb), occurrence rate of transfusion, changes of blood urea nitrogen (BUN) and creatinine (Cr), serum electrolytes, white blood cells (WBC), as well as body temperature and adverse events rate at 24 hours and 7 ± 3 days post PNL operation.
  
  
  RESULTS
  No significant differences were found between the trial group and the control group (P>0.05), in terms of patients demography, renal characteristics and stone characteristics. In the trial group and the control group, respectively: the postoperative stone-free rate was 76.74% and 79.07% (P=0.796) and the partial stone clearance rate was 23.26% and 20.93% (P=0.796), the operation time was (92.49 ± 76.59) min and (87.28 ± 50.01) min (P=0.485), the stone fragmentation and extraction time was (50.16 ± 57.11) min and (40.59 ± 31.01) min (P=0.976), the volume of extracted stones was (10.85 ± 20.08) mL and (5.05 ± 6.00) mL (P=0.041). There were also no significant differences in postoperative RBC and Hb drops, occurrence rate of transfusion, post-operative BUN and Cr, body temperature changes, postoperative systemic inflammatory response and adverse events rate at 24 hours and 7 ± 3 days post-operation between the trial and control groups (P>0.05).
  
  
  CONCLUSIONS
  There is no significant difference in clinical safety, efficacy, and the stone clearance capability between CQS-01 device and EMS-III device.
authors.affiliation: Department of Urology, Peking University People's Hospital, Beijing 100034, China.
authors.forename: Liu-lin
authors.initials: LL
authors.lastname: Xiong
authors.forename: Xiao-bo
authors.initials: XB
authors.lastname: Huang
authors.forename: Jian-xing
authors.initials: JX
authors.lastname: Li
authors.forename: Qing-quan
authors.initials: QQ
authors.lastname: Xu
authors.forename: Xiong-jun
authors.initials: XJ
authors.lastname: Ye
authors.forename: Bo
authors.initials: B
authors.lastname: Yang
authors.forename: Kai
authors.initials: K
authors.lastname: Ma
authors.forename: Liang
authors.initials: L
authors.lastname: Chen
authors.forename: Wei-guo
authors.initials: WG
authors.lastname: Hu
authors.forename: Xiao-feng
authors.initials: XF
authors.lastname: Wang
mesh_terms: D000328:Adult; D004867:Equipment Design; D005260:Female; D006801:Humans; D007669:Kidney Calculi / Q000628:therapy*; D008096:Lithotripsy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D008297:Male; D009403:Nephrostomy, Percutaneous; D012449:Safety; D014514:Ureteral Calculi / Q000628:therapy*; D055815:Young Adult