Zamenix R机器人柔性输尿管镜系统在逆行性肾内手术的初步临床评估中显示出有效性和安全性。

Robotic flexible ureteroscopy system, Zamenix R, demonstrates efficacy and safety in initial clinical evaluation for retrograde intrarenal surgery.

作者信息

Kim Joonhwan, Park Hyeji, Kwon Dong-Soo, Lee Joo Yong, Cho Sung Yong

机构信息

ROEN Surgical, Inc, Daejeon, Korea.

Department of Urology, Seoul National University Hospital, Seoul, Korea.

出版信息

Sci Rep. 2025 May 19;15(1):17366. doi: 10.1038/s41598-025-94031-z.

Abstract

This initial clinical trial evaluated the efficacy and safety of the retrograde intrarenal surgery using the robotic flexible ureteroscopy system, Zamenix R, in a multi-center, prospective, single-arm study. A total of 47 adult Korean patients with one or more kidney stones, ranging in maximal size from 5 to 30 mm, were recruited, and 46 patients were included in the analysis. The median age of patients was 57.50 [IQR 48.25-63.00] years, with a median of 1.00 [IQR 1.00-2.00] stones per patient and a median maximal size of 13.70 [IQR, 10.00-16.00] mm and a volume of 349.65 [IQR 201.60-704.10] mm³. The stone-free rates were 93.48% (< 4 mm), 71.74% (< 2 mm), and 56.52% (zero stone), based on each respective stone-free definition, with no conversions to conventional surgery. The median operative time was 91.50 [IQR 64.25-113.75] minutes, with a median console time of 71.00 [IQR 39.25-92.75] minutes. Ureteral injuries occurred in 17.39% of cases, including 6.52% Grade I and 10.87% Grade II injuries, all related to manual insertion of a ureteral access sheath. The postoperative complication rate was 6.52%, with all cases being Grade II urinary tract infections. Laser ablation speed was higher for larger stones. The operators reported low levels of musculoskeletal fatigue and numbness. The results demonstrated the efficacy and safety of the robot-assisted flexible ureteroscopic surgery using Zamenix R. Further investigation is required, including a comparison with the standard of care and a larger sample size.

摘要

这项初始临床试验在一项多中心、前瞻性、单臂研究中评估了使用机器人柔性输尿管镜系统Zamenix R进行逆行性肾内手术的疗效和安全性。共招募了47名患有一个或多个肾结石的成年韩国患者,结石最大尺寸为5至30毫米,46名患者纳入分析。患者的中位年龄为57.50岁[四分位间距48.25 - 63.00岁],每位患者的结石中位数量为1.00个[四分位间距1.00 - 2.00个],结石最大尺寸中位值为13.70毫米[四分位间距10.00 - 16.00毫米],体积为349.65立方毫米[四分位间距201.60 - 704.10立方毫米]。根据各自的无结石定义,无结石率分别为93.48%(<4毫米)、71.74%(<2毫米)和56.52%(无结石残留),且无一例转为传统手术。中位手术时间为91.50分钟[四分位间距64.25 - 113.75分钟],中位控制台操作时间为71.00分钟[四分位间距39.25 - 92.75分钟]。输尿管损伤发生率为17.39%,包括6.52%的Ⅰ级损伤和10.87%的Ⅱ级损伤,均与手动插入输尿管鞘有关。术后并发症发生率为6.52%,所有病例均为Ⅱ级尿路感染。较大结石的激光消融速度更高。操作者报告肌肉骨骼疲劳和麻木程度较低。结果证明了使用Zamenix R进行机器人辅助柔性输尿管镜手术的疗效和安全性。需要进一步研究,包括与标准治疗方法进行比较以及扩大样本量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57f0/12089433/103840003a0d/41598_2025_94031_Fig1_HTML.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索