INTRODUCTION This was a prospective, first-in-human trial to evaluate the feasibility and safety of insertion of biopsy introducer needles with our robot during CT fluoroscopy-guided biopsy in humans. MATERIALS AND METHODS Eligible patients were adults with a lesion ≥ 10 mm in an extremity or the trunk requiring pathological diagnosis with CT fluoroscopy-guided biopsy. Patients in whom at-risk structures were located within 10 mm of the scheduled needle tract were excluded. Ten patients (4 females and 6 males; mean [range] age, 72 [52-87] years) with lesions (mean [range] maximum diameter, 28 [14-52] mm) in the kidney (n = 4), lung (n = 3), mediastinum (n = 1), adrenal gland (n = 1), and muscle (n = 1) were enrolled. The biopsy procedure involved robotic insertion of a biopsy introducer needle followed by manual acquisition of specimens using a biopsy needle. The patients were followed up for 14 days. Feasibility was defined as the distance of ≤ 10 mm between needle tip after insertion and the nearest lesion edge on the CT fluoroscopic images. The safety of robotic insertion was evaluated on the basis of machine-related troubles and adverse events according to the Clavien-Dindo classification. RESULTS Robotic insertion of the introducer needle was feasible in all patients, enabling pathological diagnosis. There was no machine-related trouble. A total of 11 adverse events occurred in 8 patients, including 10 grade I events and 1 grade IIIa event. CONCLUSION Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body. KEY POINTS • Insertion of biopsy introducer needles with our robot during CT fluoroscopy-guided biopsy was feasible at several locations in the human body.

中文翻译：

---

在计算机断层扫描荧光透视引导下的活检过程中插入机器人针头：前瞻性人类可行性试验。

简介这是一项前瞻性，首次人体试验，旨在评估在CT透视引导下的人体活检过程中，使用我们的机器人插入活检导引针的可行性和安全性。材料与方法符合条件的患者为成年人，其四肢或躯干的病变≥10 mm，需要通过CT透视引导下的活检进行病理诊断。高危结构位于计划的针道内10 mm以内的患者被排除在外。十名肾脏病变（n = 4）的患者（4名女性和6名男性；平均[范围]年龄72 [52-87]岁）（平均直径[范围]最大直径28 [14-52] mm），肺（n = 3），纵隔（n = 1），肾上腺（n = 1）和肌肉（n = 1）被纳入研究。活检过程包括自动插入活检导引针，然后使用活检针手动采集标本。随访14天。可行性定义为插入后的针尖与CT透视图像上最近的病变边缘之间的距离≤10 mm。根据与机器相关的故障和不良事件，根据Clavien-Dindo分类对机器人插入的安全性进行了评估。结果在所有患者中机器人插入导针都是可行的，从而可以进行病理诊断。没有与机器有关的麻烦。8例患者共发生11例不良事件，包括10例I级事件和1例IIIa级事件。结论用我们的机器人插入活检导引针在人体的多个位置都是可行的。要点•在CT透视引导下的活检中，用我们的机器人插入活检导引针是可行的。