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Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion\u2122 Endoluminal System) is a new tool for minimally invasive peripheral nodule biopsy. We sought to answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists\u2019 initial experience?<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The lead-in stage of a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System (PRECIsE) is described. Enrolled subjects\u2009\u2265\u200918\u00a0years old had recent computed tomography evidence of one or more solid or semi-solid pulmonary nodules\u2009\u2265\u20091.0 to\u2009\u2264\u20093.5\u00a0cm in greatest dimension and in any part of the lung. Subjects were followed at 10- and 30-days post-procedure. This stage provided investigators and staff their first human experience with the SSRAB system; safety and procedure outcomes were analyzed descriptively. Neither diagnostic yield nor sensitivity for malignancy were assessed in this stage. Categorical variables are summarized by percentage; continuous variables are summarized by median\/interquartile range (IQR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixty subjects were enrolled across 6 hospitals; 67 nodules were targeted for biopsy. Median axial, coronal and sagittal diameters were\u2009&lt;\u200918\u00a0mm with a largest cardinal diameter of 20.0\u00a0mm. Most nodules were extraluminal and distance from the outer edge of the nodule to the pleura or nearest fissure was 4.0\u00a0mm (IQR: 0.0, 15.0). Median bronchial generation count to the target location was 7.0 (IQR: 6.0, 8.0). Procedure duration (catheter-in to catheter-out) was 66.5\u00a0min (IQR: 50.0, 85.5). Distance from the catheter tip to the closest edge of the virtual nodule was 7.0\u00a0mm (IQR: 2.0, 12.0). Biopsy completion was 97.0%. No pneumothorax or airway bleeding of any grade was reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Bronchoscopists leveraged the Ion SSRAB\u2019s functionality to drive the catheter safely in close proximity of the virtual target and to obtain biopsies. This initial, multicenter experience is encouraging, suggesting that SSRAB may play a role in the management of pulmonary nodules.<\/jats:p>\n                    <jats:p>\n                      <jats:italic>Clinical Trial Registration identifier and date<\/jats:italic>\n                      NCT03893539; 28\/03\/2019.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12890-021-01693-2","type":"journal-article","created":{"date-parts":[[2021,10,16]],"date-time":"2021-10-16T14:22:07Z","timestamp":1634394127000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":78,"title":["Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion\u2122 Endoluminal System"],"prefix":"10.1186","volume":"21","clinical-trial-number":[{"clinical-trial-number":"nct03893539","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Michael J.","family":"Simoff","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael A.","family":"Pritchett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janani S.","family":"Reisenauer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E.","family":"Ost","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adnan","family":"Majid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen","family":"Keyes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto F.","family":"Casal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihir S.","family":"Parikh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Diaz-Mendoza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Fernandez-Bussy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik E.","family":"Folch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,10,16]]},"reference":[{"issue":"10","key":"1693_CR1","doi-asserted-by":"publisher","first-page":"1208","DOI":"10.1164\/rccm.201505-0990OC","volume":"192","author":"MK Gould","year":"2015","unstructured":"Gould MK, Tang T, Liu IL, et al. 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Study subject confidentiality was maintained according to the Health Insurance Portability and Accountability Act requirements. All research was performed in accordance with the 1964 Declaration of Helsinki and its amendments. Study sites, IRB committee names, and approval numbers follow: Mayo Clinic: Mayo Clinic IRB 18-011348; First Health Moore Regional Hospital: Western IRB 20183121; Massachusetts General Hospital: Dana Farber Cancer Institute IRB 19-209; Beth Israel Deaconess Medical Center: Dana Farber Cancer Institute IRB 19-209; Henry Ford Hospital: Henry Ford Health System IRB\u00a012822; University of Texas MD Anderson Cancer Center: MD Anderson Cancer Center IRB IRB00006023.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MJS has received research and manuscript support from Intuitive Surgical and consulting fees and research support from Gongwin Biopharm. MAP has received consulting and speaker fees and research support from Johnson & Johnson, Medtronic, BodyVision, and Intuitive Surgical; research support from Philips; speaker fees and research support from Biodesix; consulting and speaker fees from AstraZeneca; speaker fees from Boeinger-Ingleheim; speaker fees and research support from United Therapeutics; speaker fees and research support from Actelion; research support from Inivata; consulting fees from Boston Scientific; consulting fees from OncoSec; consulting fees from Ambu; consulting fees and stock from HealthMyne. JSR has received research support and an educational grant from Intuitive Surgical. DEO has received research support, a research grant, and consulting fees from Intuitive Surgical. AM has received research support from Intuitive Surgical, consulting fees from Olympus America, and a research grant from Bronchus Medical. CK has received consulting fees and research support from Intuitive Surgical. RFC has received research support from Olympus, Concordia, Intuitive Surgical, and Siemens and consulting fees from Olympus, Siemens, Intuitive Surgical, Johnson & Johnson, and Bronx. MSP has received research support and educational consultant fees from Intuitive Surgical. JD-M has received research support from Intuitive Surgical. SF-B has received research support from Intuitive Surgical. EEF has received a research grant from Intuitive Surgical and consulting fees from Boston Scientific and Medtronic.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"322"}}