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Eur Urol Open Sci ; 49: 6-9, 2023 Mar.
Article in English | MEDLINE | ID: covidwho-2178647

ABSTRACT

The coronavirus disease 2019 pandemic has drawn attention to telesurgery. Important advances in fifth-generation (5G) mobile telecommunication technology have facilitated the rapid evolution of telesurgery. Previously, only a single console was used in telesurgery; thus, there was the possibility of open or laparoscopic conversion. Furthermore, the 5G network has not been available for regional hospitals in China. From October 2021 to April 2022, dual-console telesurgeries with the KangDuo Surgical Robot-01 (KD-SR-01) system were performed using 5G and wired networks in an animal experiment and clinical study. A partial nephrectomy in a porcine model was performed successfully using a wired network. The console time, warm ischemia time, and control swap time were 69 min, 27 min, and 3 s, respectively. The mean latency time was 130 (range, 60-200) ms. A 32-yr-old male patient successfully underwent a remote pyeloplasty using a series connection of 5G wireless and wired networks. The console time and control swap time were 98 min and 3 s, respectively. The mean latency time was 271 (range, 206-307) ms. In the two studies, data pocket loss was <1%. The results demonstrated that dual-console telesurgery with the KD-SR-01 system is feasible and safe using 5G and wired networks. Patient summary: Advances in fifth-generation (5G) mobile telecommunication technology helped in the rapid evolution of telesurgery. Dual-console telesurgery performed with the KD-SR-01 system using 5G and wired networks was shown to be feasible and safe in an animal experiment and clinical study.

2.
EBioMedicine ; 75: 103811, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1638699

ABSTRACT

BACKGROUND: We report on the safety and immunogenicity of V591, a measles vector-based SARS-CoV-2 vaccine candidate. METHODS: In this multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial, healthy adults with no history of COVID-19 disease were assigned to intramuscular injection of V591 or placebo (4:1 ratio). In part 1, younger adults (18-55 years) received V591 median tissue culture infectious dose (TCID50)-levels of 1×105 or 1×106 or placebo, 56 days apart. In part 2, younger and older (>55 years) adults received a single dose of one of four (104/105/106/107) or one of two (105/106) V591 TCID50 levels, respectively, or placebo. PRIMARY OUTCOME: safety/tolerability. Secondary outcome: humoral immunogenicity. ClinicalTrials.gov: NCT04498247. FINDINGS: From August-December 2020, 444 participants were screened and 263 randomised (210 V591; 53 placebo); 262 received at least one and 10 received two doses of V591 or placebo. Adverse events were experienced by 140/209 (67.0%) V591 dose-group participants and 37/53 (69.8%) placebo-group participants following injection 1; most frequent were fatigue (57 [27.3%] vs 20 [37.7%]), headache (57 [27.3%] vs 19 [35.8%]), myalgia (35 [16.7%] vs 10 [18.9%]), and injection-site pain (35 [16.7%] vs 4 [7.5%]). No deaths nor vaccine-related serious adverse events occurred. At Day 29, no anti-SARS-CoV-2 spike serum neutralising antibody and IgG-responses were identified in placebo or the three lower V591 dose-groups; responses were detected with V591 1×107 TCID50, although titres were lower than convalescent serum. INTERPRETATION: V591 was generally well tolerated, but immunogenicity was insufficient to warrant continued development. FUNDING: Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/immunology , Genetic Vectors , Immunogenicity, Vaccine , Measles virus , SARS-CoV-2/immunology , Adolescent , Adult , COVID-19/genetics , COVID-19/prevention & control , COVID-19 Vaccines/genetics , COVID-19 Vaccines/immunology , Double-Blind Method , Female , Humans , Male , Middle Aged , SARS-CoV-2/genetics
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