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Asian Journal of Urology, 2023, 10(3): 364-371    doi: 10.1016/j.ajur.2022.01.001
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A pilot clinical study of developing an External Assist Targeting Device for rapid and precise renal calyx access during percutaneous nephrolithotomy
Qinghui Wua,Kesavan Esuvaranathanab,Teck Kheng Leec,Soo Leong Fooc,Jian Ping Chaid*(),Edmund Chiongab
a Department of Urology, National University Hospital, Singapore
b Department of Surgery, National University of Singapore, Singapore
c Institute of Technical Education, Technology Development Centre, Singapore
d Invivo Medical Pte. Ltd., Singapore
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Abstract: 

Objective To design a device to increase the accuracy of the targeting process and reduce the radiation exposure to both the patients and the medical staff.
Methods We analyzed the inherent problem and designed the External Assist Targeting Device (EATD) to assist in the alignment of needle targeting on the desired renal calyx under fluoroscopic guidance. The EATD was designed to allow rapid and precise access to calyces at all angles, with a simple two-step puncture protocol developed for puncturing a target renal calyx. We then tested the device in a pilot human trial with four patients.
Results In experiments with phantom models, the time for successful targeting was reduced by 31% using the device. The mean fluoroscopic time was reduced by 40%. In initial human trial, the puncture time was shortened by 66% and the radiation dose was decreased by 65% compared to free-hand technique. No complication was observed during the trial.
Conclusion The EATD was found to be cost effective, portable, simple to set up, and safe to operate for assisting in the percutaneous nephrolithotomy procedures. Our preliminary tests showed high degree of accuracy in gaining precise access to a targeted renal calyx with much shorter time and lesser radiation dose. The EATD also has the potential to be used to access other organs with precision under fluoroscopic guidance.

Key words:  Percutaneous nephrolithotomy    Kidney puncture    Renal calculi    Targeting device    Fluoroscopy guidance
收稿日期:  2021-05-28           接受日期:  2021-11-04           发布日期:  2023-08-11      整期出版日期:  2023-07-20
引用本文:    
. [J]. Asian Journal of Urology, 2023, 10(3): 364-371.
Qinghui Wu,Kesavan Esuvaranathan,Teck Kheng Lee,Soo Leong Foo,Jian Ping Chai,Edmund Chiong. A pilot clinical study of developing an External Assist Targeting Device for rapid and precise renal calyx access during percutaneous nephrolithotomy. Asian Journal of Urology, 2023, 10(3): 364-371.
链接本文:  
http://www.ajurology.com/CN/10.1016/j.ajur.2022.01.001  或          http://www.ajurology.com/CN/Y2023/V10/I3/364
  
  
  
  
  
Group Mean puncture time Mean fluoroscope screening time
Conventional free-hand, s With EATD, s Improvement, % Conventional free-hand, s With EATD, s Improvement, %
Urologist 87 60 31 20 12 40
Engineer (untrained in PCNL) NA 117 NA NA 19 NA
  
Method Number of trials, n Successful puncture in the 1st attempt, n Successful puncture in >1 attempt, n
Conventional free-hand 6 4 2
With EATD 7 7 0
  
Demographic and clinical characteristic Device (n=9) Control (n=4) p-Value
Mean age, year 55.2 46.3 0.09
Gender, n (%)
Male 4 (44.4) 2 (50.0) 0.85
Female 5 (55.6) 2 (50.0) 0.67
Laterality, left, n (%) 5 (55.6) 2 (50.0) 0.43
Mean stone size, mm 35.5 37.2 0.44
Hydronephrosis, n (%)
No 6 (66.7) 2 (50.0) 0.57
Yes 3 (33.3) 2 (50.0) 0.96
Mean time for puncture, min 5.2 15.2 <0.01
Mean radiation dose, mGy 6.8 19.3 <0.01
  
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