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 language | English |
---|---|
Title of host publication | Proceedings of the 2023 Design of Medical Devices Conference, DMD 2023 |
Publisher | American Society of Mechanical Engineers |
ISBN (Electronic) | 9780791886731 |
DOIs | |
State | Published - 2023 |
Event | 2023 Design of Medical Devices Conference, DMD 2023 - Minneapolis, United States Duration: 17 Apr 2023 → 21 Apr 2023 |
Publication series
Name | Proceedings of the 2023 Design of Medical Devices Conference, DMD 2023 |
---|
Conference
Conference | 2023 Design of Medical Devices Conference, DMD 2023 |
---|---|
Country/Territory | United States |
City | Minneapolis |
Period | 17/04/23 → 21/04/23 |
Bibliographical note
Publisher Copyright:© 2023 by ASME.
Keywords
- Clinical study
- Flexible ureteroscopy
- In-vivo study
- Kidney stone
- Retrograde intrarenal surgery
- Robot-Assisted