SESSION TITLE: Late Breaking Procedures PostersSESSION TYPE: Original Investigation PostersPRESENTED ON: 10/18/2022 01:30 pm - 02:30 pmPURPOSE: The Galaxy System™ (Noah Medical, San Carlos, CA) is a novel robotic endoluminal platform using electromagnetic navigation combined with integrated tomosynthesis technology and augmented fluoroscopy. It provides intraprocedural imaging to correct CT-to-body divergence and novel confirmation of tool-in-lesion. The primary aim of this study was to assess the tool-in-lesion accuracy of the robotic bronchoscope with integrated digital tomosynthesis and augmented fluoroscopy.METHODS: Over four separate days, four operators (the authors) conducted the experiment using four pigs. Each physician performed between 4 and 6 nodule biopsies for 20 lung nodule biopsies. A porcine model (S. s. domesticus) was utilized. Each pig was anesthetized with volatile gas and underwent tracheostomy with an 8.5 endotracheal tube and bilateral chest tube thoracostomy. Anesthesia was monitored by a veterinarian with invasive hemodynamic monitoring. Under CT fluoroscopic guidance, simulated lung nodules were created by percutaneous injection of a gelatinous agar solution containing purple dye and radiopaque material into the lung periphery. A CT was then performed for pre-procedure planning. Using Galaxy’s “Tool in Lesion TOMO+” with augmented fluoroscopy, the physician navigated to the lung nodules and a tool (needle) was placed into the lesion. Tool in lesion was defined by the needle in or tangential to the lesion determined by CBCT. Center strike was defined as the needle in the middle third in three orthogonal angles (axial, sagittal, and coronal) on CBCT.RESULTS: Lung nodules’ average size was 16.3±0.97 mm and were predominantly in the lower lobes (65%). Only 15% (3/20) had a bronchus sign and the average distance to the pleura was 6.88±5.5 mm. All four operators successfully navigated to all (100%) of the lesions in an average of 3 minutes and 39 seconds. The median number of tomosynthesis sweeps was 3 and augmented fluoroscopy was utilized in most cases (17/20 or 85%). Tool in lesion after final tomography sweep was 100% (20/20). Biopsy yielding purple pigmentation on microscopic or gross examination was also 100% (20/20). Center strike rate was 60%.CONCLUSIONS: The Galaxy System™ demonstrated successful digital tomography confirmed tool in lesion success in 100% (20/20) of lesions as confirmed by CBCT. Successful biopsy was achieved in 100% of lesions as confirmed by intralesional pigment acquisition.CLINICAL IMPLICATIONS: The combination of robotic navigation, catheter maneuverability and real-time correction for CT body divergence capitalizes on the strengths of all three technologies to improve diagnosis. Additional clinical trials are warranted to see if high success rates can be reproduced in patients.DISCLOSURES:Consultant relationship with Medtronic ILS Please note: $20001 - $100000 by Krish Bhadra, value=Consulting feeConsultant relationship with Veractye Please note: $1-$1000 by Krish Bhadra, value=Consulting feeConsultant relationship with Bodyvision Please note: $1001 - $5000 by Krish Bhadra, value=Consulting feeConsultant relationship with Merit Endotek Please note: $1001 - $5000 by Krish Bhadra, value=Consulting feeConsultant relationship with Boston Scientific Please note: $1001 - $5000 by Krish Bhadra, value=Consulting feeHuman Factor Testing relationship with Auris Surgical Robotics Please note: $1001 - $5000 by Krish Bhadra, value=Consulting feeConsultant relationship with Intuitive Surgical Robotics Please note: $5001 - $20000 by Krish Bhadra, value=Consulting feeConsultant relationship with Biodesix Please note: $5001 - $20000 by Krish Bhadra, value=Consulting feeConsultant relationship with Noah Medical Please note: 5/2020 Added 06/01/2022 by Krish Bhadra, value=Consulting feeSpeaker relationship with Body Vision Please note: 2015 - present Added 05/29/2022 by Douglas Hogarth, value=Ownership interestConsultant relationship with Magnisity Please note: 2021 - present Added 05/29/2022 by Douglas Hogarth, value=Ownership interestConsultant relationship with Auris (J&J Ethicon) Please note: 2014-present Added 05/29/2022 by Douglas Hogarth, value=HonorariaConsultant relationship with Boston Scientific Please note: 2008 - present Added 05/29/2022 by Douglas Hogarth, value=Consulting feeConsultant relationship with Medtronic Please note: 2010-2019 Added 05/29/2022 by Douglas Hogarth, value=Consulting feeConsultant relationship with Broncus Please note: 2017-2021 Added 05/29/2022 by Douglas Hogarth, value=Consulting feeConsultant relationship with PulmonX Please note: $5001 - $20000 by Douglas Hogarth, value=Consulting feeRemoved 06/08/2022 by Douglas HogarthConsultant relationship with Spiration Please note: $5001 - $20000 by Douglas Hogarth, value=Consulting feeRemoved 06/08/2022 by Douglas HogarthConsultant relationship with Eolo Please note: $20001 - $100000 by Douglas Hogarth, value=Ownership interestRemoved 06/08/2022 by Douglas HogarthConsultant relationship with Noah Please note: 2019 - present Added 06/08/2022 by Douglas Hogarth, value=Ownership interestConsultant relationship with Noah Please note: 2019 - present Added 06/08/2022 by Douglas Hogarth, value=Consulting feeConsultant relationship with Medtronic Corporation Please note: $5001 - $20000 by Amit Mahajan, value=Consulting feeConsultant relationship with Boston Scientific Corporation Please note: $1001 - $5000 by Amit Mahajan, value=Consulting feeConsultant relationship with Pulmonx Corporation Please note: $5001 - $20000 by Amit Mahajan, value=Consulting feeConsultant relationship with Ambu USA Please note: $1-$1000 by Amit Mahajan, value=Consulting feeConsultant relationship with Circulogene Please note: $1001 - $5000 by Amit Mahajan, value=Consulting feeConsultant relationship with Medtronic/Covidien Please note: $1001 - $5000 by Otis Rickman, value=Consulting fee SESSION TITLE: Late Breaking Procedures Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/18/2022 01:30 pm - 02:30 pm PURPOSE: The Galaxy System™ (Noah Medical, San Carlos, CA) is a novel robotic endoluminal platform using electromagnetic navigation combined with integrated tomosynthesis technology and augmented fluoroscopy. It provides intraprocedural imaging to correct CT-to-body divergence and novel confirmation of tool-in-lesion. The primary aim of this study was to assess the tool-in-lesion accuracy of the robotic bronchoscope with integrated digital tomosynthesis and augmented fluoroscopy. METHODS: Over four separate days, four operators (the authors) conducted the experiment using four pigs. Each physician performed between 4 and 6 nodule biopsies for 20 lung nodule biopsies. A porcine model (S. s. domesticus) was utilized. Each pig was anesthetized with volatile gas and underwent tracheostomy with an 8.5 endotracheal tube and bilateral chest tube thoracostomy. Anesthesia was monitored by a veterinarian with invasive hemodynamic monitoring. Under CT fluoroscopic guidance, simulated lung nodules were created by percutaneous injection of a gelatinous agar solution containing purple dye and radiopaque material into the lung periphery. A CT was then performed for pre-procedure planning. Using Galaxy’s “Tool in Lesion TOMO+” with augmented fluoroscopy, the physician navigated to the lung nodules and a tool (needle) was placed into the lesion. Tool in lesion was defined by the needle in or tangential to the lesion determined by CBCT. Center strike was defined as the needle in the middle third in three orthogonal angles (axial, sagittal, and coronal) on CBCT. RESULTS: Lung nodules’ average size was 16.3±0.97 mm and were predominantly in the lower lobes (65%). Only 15% (3/20) had a bronchus sign and the average distance to the pleura was 6.88±5.5 mm. All four operators successfully navigated to all (100%) of the lesions in an average of 3 minutes and 39 seconds. The median number of tomosynthesis sweeps was 3 and augmented fluoroscopy was utilized in most cases (17/20 or 85%). Tool in lesion after final tomography sweep was 100% (20/20). Biopsy yielding purple pigmentation on microscopic or gross examination was also 100% (20/20). Center strike rate was 60%. CONCLUSIONS: The Galaxy System™ demonstrated successful digital tomography confirmed tool in lesion success in 100% (20/20) of lesions as confirmed by CBCT. Successful biopsy was achieved in 100% of lesions as confirmed by intralesional pigment acquisition. CLINICAL IMPLICATIONS: The combination of robotic navigation, catheter maneuverability and real-time correction for CT body divergence capitalizes on the strengths of all three technologies to improve diagnosis. Additional clinical trials are warranted to see if high success rates can be reproduced in patients. DISCLOSURES: Consultant relationship with Medtronic ILS Please note: $20001 - $100000 by Krish Bhadra, value=Consulting fee Consultant relationship with Veractye Please note: $1-$1000 by Krish Bhadra, value=Consulting fee Consultant relationship with Bodyvision Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Consultant relationship with Merit Endotek Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Human Factor Testing relationship with Auris Surgical Robotics Please note: $1001 - $5000 by Krish Bhadra, value=Consulting fee Consultant relationship with Intuitive Surgical Robotics Please note: $5001 - $20000 by Krish Bhadra, value=Consulting fee Consultant relationship with Biodesix Please note: $5001 - $20000 by Krish Bhadra, value=Consulting fee Consultant relationship with Noah Medical Please note: 5/2020 Added 06/01/2022 by Krish Bhadra, value=Consulting fee Speaker relationship with Body Vision Please note: 2015 - present Added 05/29/2022 by Douglas Hogarth, value=Ownership interest Consultant relationship with Magnisity Please note: 2021 - present Added 05/29/2022 by Douglas Hogarth, value=Ownership interest Consultant relationship with Auris (J&J Ethicon) Please note: 2014-present Added 05/29/2022 by Douglas Hogarth, value=Honoraria Consultant relationship with Boston Scientific Please note: 2008 - present Added 05/29/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with Medtronic Please note: 2010-2019 Added 05/29/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with Broncus Please note: 2017-2021 Added 05/29/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with PulmonX Please note: $5001 - $20000 by Douglas Hogarth, value=Consulting fee Removed 06/08/2022 by Douglas Hogarth Consultant relationship with Spiration Please note: $5001 - $20000 by Douglas Hogarth, value=Consulting fee Removed 06/08/2022 by Douglas Hogarth Consultant relationship with Eolo Please note: $20001 - $100000 by Douglas Hogarth, value=Ownership interest Removed 06/08/2022 by Douglas Hogarth Consultant relationship with Noah Please note: 2019 - present Added 06/08/2022 by Douglas Hogarth, value=Ownership interest Consultant relationship with Noah Please note: 2019 - present Added 06/08/2022 by Douglas Hogarth, value=Consulting fee Consultant relationship with Medtronic Corporation Please note: $5001 - $20000 by Amit Mahajan, value=Consulting fee Consultant relationship with Boston Scientific Corporation Please note: $1001 - $5000 by Amit Mahajan, value=Consulting fee Consultant relationship with Pulmonx Corporation Please note: $5001 - $20000 by Amit Mahajan, value=Consulting fee Consultant relationship with Ambu USA Please note: $1-$1000 by Amit Mahajan, value=Consulting fee Consultant relationship with Circulogene Please note: $1001 - $5000 by Amit Mahajan, value=Consulting fee Consultant relationship with Medtronic/Covidien Please note: $1001 - $5000 by Otis Rickman, value=Consulting fee