Robotic needle insertion during computed tomography fluoroscopy–guided biopsy: prospective first-in-human feasibility trial

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.