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.