Hinata Nobuyuki, Yamaguchi Raizo, Kusuhara Yoshito, Kanayama Hiroomi, Kohjimoto Yasuo, Hara Isao, Fujisawa Masato
Department of Urology, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Int J Urol. 2022 Oct;29(10):1213-1220. doi: 10.1111/iju.14973. Epub 2022 Jul 18.
To evaluate the safety and efficacy of the hinotori™ Surgical Robot System in preclinical and clinical studies.
Preclinical studies on 10 living female porcine and four fresh male cadavers were conducted. Different types of urologic surgical procedures were performed by experienced urological surgeons using the hinotori system: partial nephrectomy, vesicourethral anastomosis, and pelvic lymph node dissection in porcine, and partial nephrectomy, radical prostatectomy, and pelvic lymph node dissection in cadavers. In a multi-institutional single-arm clinical study, radical prostatectomy was performed in 30 patients with localized prostate cancer to evaluate safety outcomes. The primary endpoint was safety profiles, including device errors and perioperative complications, and the secondary endpoints were console time, blood loss, and positive surgical margin rate.
The preclinical results were similar to those reported for the daVinci surgical system. The performance of the hinotori was equivalent to that of the daVinci surgical system, based on a global assessment by the surgeons. Safety was confirmed in a first-in-human clinical study of robot-assisted radical prostatectomy using hinotori in 30 patients. The procedures were completed as planned in all cases, and three (10%) perioperative adverse events were observed.
The safety of the newly developed hinotori surgical system was shown in the present preclinical and clinical studies. Further studies are required to confirm its clinical efficacy.
在临床前和临床研究中评估日之鸟™手术机器人系统的安全性和有效性。
对10只活体雌性猪和4具新鲜雄性尸体进行了临床前研究。经验丰富的泌尿外科医生使用日之鸟系统进行了不同类型的泌尿外科手术：猪的部分肾切除术、膀胱尿道吻合术和盆腔淋巴结清扫术，以及尸体的部分肾切除术、根治性前列腺切除术和盆腔淋巴结清扫术。在一项多机构单臂临床研究中，对30例局限性前列腺癌患者进行了根治性前列腺切除术以评估安全性结果。主要终点是安全性概况，包括设备故障和围手术期并发症，次要终点是控制台操作时间、失血量和手术切缘阳性率。
临床前结果与达芬奇手术系统报告的结果相似。根据外科医生的整体评估，日之鸟的性能与达芬奇手术系统相当。在30例使用日之鸟进行机器人辅助根治性前列腺切除术的人体首次临床研究中证实了安全性。所有病例均按计划完成手术，观察到3例（10%）围手术期不良事件。
新开发的日之鸟手术系统的安全性在目前的临床前和临床研究中得到了证明。需要进一步研究以确认其临床疗效。
