INTRODUCTION: Shape-sensing robotic-assisted bronchoscopy (ssRAB) was shown to be superior in diagnosing peripheral pulmonary nodules (PPNs) compared to conventional bronchoscopy. Although RAB is established in the USA since 2019, the ION Endoluminal System was not CE marked in Europe until 2023. METHODS: The first prospective European single-center, premarket study, conducted between 2022 and 2023, assessed the diagnosis of PPNs with ssRAB, using the ION Endoluminal System. Patients with suspected lung cancer or metastasis, PPNs of 1-3 cm, and >/=3 airway generations out were included in this study and followed up for up to 6 months. The primary outcome was the rate of tool-in-lesion (TIL), confirmed by mobile cone-beam computed tomography or with malignant index biopsy finding. Secondary outcomes included procedural characteristics, diagnostic yield, and adverse events. RESULTS: A total of 43 patients with a mean nodule size of 19.2 x 16.9 x 15.8 mm, a mean distance of 17.4 +/- 15.5 mm to the pleura, and mean 6.6th generation of airway were analyzed. TIL was achieved in 90.7% of all cases. Strict diagnostic yield was 67.4% and sensitivity for malignancy was 78.6%. No pneumothorax and no adverse events were reported outside of 3 cases of Nashville
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