Zamenix R, robotic-Assisted retrograde intrarenal surgery system for renal stone removal and its efficacy and safety evaluation

Dong Ho Lee, Joonhwan Kim, Jungmin Han, Hyeonse Seo, Joo Yong Lee, Sung Yong Cho, Hyung Keun Park, Dong Soo Kwon

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

Abstract

We introduce Zamenix R, a novel robotic retrograde intrarenal surgery (RIRS) system that can remotely control a ureteroscope, laser, and stone basket. The efficacy and safety of the system were explored in an in vivo comparative pilot study using a porcine model and a multicenter, prospective, single-Arm, pivotal human clinical trial. In the in-vivo test, 10 pigs were randomly divided into two groups: conventional RIRS and robotic RIRS. Three surgeons with different RIRS proficiency participated and they performed two tasks: 1) Stone retrieval test, then followed by 2) Stone fragmentation and retrieval test. In the clinical study, forty-seven adult patients who have one or more stones with a maximum size of 5-30 mm were recruited. The stone-free rate was 93.5%. The postoperative complication rate was 6.5% with three cases of Grade II urinary tract infection (Clavien-Dindo Classification). The experimental results demonstrated the feasibility and comparable safety to conventional RIRS with improved operator s fatigue and radiation exposure.

Original languageEnglish
Title of host publicationProceedings of the 2023 Design of Medical Devices Conference, DMD 2023
PublisherAmerican Society of Mechanical Engineers
ISBN (Electronic)9780791886731
DOIs
StatePublished - 2023
Event2023 Design of Medical Devices Conference, DMD 2023 - Minneapolis, United States
Duration: 17 Apr 202321 Apr 2023

Publication series

NameProceedings of the 2023 Design of Medical Devices Conference, DMD 2023

Conference

Conference2023 Design of Medical Devices Conference, DMD 2023
Country/TerritoryUnited States
CityMinneapolis
Period17/04/2321/04/23

Bibliographical note

Publisher Copyright:
© 2023 by ASME.

Keywords

  • Clinical study
  • Flexible ureteroscopy
  • In-vivo study
  • Kidney stone
  • Retrograde intrarenal surgery
  • Robot-Assisted

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