NCT06654271|Active Not RecruitingDMCFDA Device
Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging
RELIANT 2
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Sponsor study identifier
interventional
440
1 country
4
Study Start
November 11, 2024
Actual (reported)Primary Completion
October 14, 2025
Actual (reported)Study Completion
October 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2024
Actual (reported)October 23, 2024
Actual (reported)November 11, 2024
Actual (reported)October 14, 2025
Actual (reported)October 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified: * Malignancy * Specific benign pathologic findings including: * Organizing pneumonia * Frank purulence/robust neutrophilic inflammation * Granulomatous inflammation * Other specific benign findings such as hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns as adjudicated by an expert lung pathologist.
7 days post-procedure
Duration of bronchoscopy (in minutes)
Duration of procedure, approximately 60 minutes
Robotic assisted bronchoscopy with integrated cone beam computed tomography
Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis
Participants allocated to the robotic assisted bronchoscopy arm will undergo robotic assisted bronchoscopy with integrated cone beam computed tomography
Participants allocated to the electromagnetic navigation bronchoscopy arm will undergo electromagnetic navigation bronchoscopy with integrated digital tomosynthesis
Rush University Medical Center
Chicago, Illinois, 60612, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Zhang C, Xie F, Li R, Cui N, Herth FJF, Sun J. Robotic-assisted bronchoscopy for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis. Thorac Cancer. 2024 Mar;15(7):505-512. doi: 10.1111/1759-7714.15229. Epub 2024 Jan 29.
Kalchiem-Dekel O, Connolly JG, Lin IH, Husta BC, Adusumilli PS, Beattie JA, Buonocore DJ, Dycoco J, Fuentes P, Jones DR, Lee RP, Park BJ, Rocco G, Chawla M, Bott MJ. Shape-Sensing Robotic-Assisted Bronchoscopy in the Diagnosis of Pulmonary Parenchymal Lesions. Chest. 2022 Feb;161(2):572-582. doi: 10.1016/j.chest.2021.07.2169. Epub 2021 Aug 9.
Rafael Paez, MD
Vanderbilt University Medical Center
440 participants (actual enrollment reported by the registry).
First Submitted
October 21, 2024
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Low SW, Lentz RJ, Chen H, Katsis J, Aboudara MC, Whatley S, Paez R, Rickman OB, Maldonado F. Shape-Sensing Robotic-Assisted Bronchoscopy vs Digital Tomosynthesis-Corrected Electromagnetic Navigation Bronchoscopy: A Comparative Cohort Study of Diagnostic Performance. Chest. 2023 Apr;163(4):977-984. doi: 10.1016/j.chest.2022.10.019. Epub 2022 Oct 29.
Katsis J, Roller L, Aboudara M, Pannu J, Chen H, Johnson J, Lentz RJ, Rickman O, Maldonado F. Diagnostic Yield of Digital Tomosynthesis-assisted Navigational Bronchoscopy for Indeterminate Lung Nodules. J Bronchology Interv Pulmonol. 2021 Oct 1;28(4):255-261. doi: 10.1097/LBR.0000000000000766.
Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC.
Nadig TR, Thomas N, Nietert PJ, Lozier J, Tanner NT, Wang Memoli JS, Pastis NJ, Silvestri GA. Guided Bronchoscopy for the Evaluation of Pulmonary Lesions: An Updated Meta-analysis. Chest. 2023 Jun;163(6):1589-1598. doi: 10.1016/j.chest.2022.12.044. Epub 2023 Jan 11.
Criner GJ, Eberhardt R, Fernandez-Bussy S, Gompelmann D, Maldonado F, Patel N, Shah PL, Slebos DJ, Valipour A, Wahidi MM, Weir M, Herth FJ. Interventional Bronchoscopy. Am J Respir Crit Care Med. 2020 Jul 1;202(1):29-50. doi: 10.1164/rccm.201907-1292SO.
Agrawal A, Hogarth DK, Murgu S. Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data. J Thorac Dis. 2020 Jun;12(6):3279-3286. doi: 10.21037/jtd.2020.03.35.
Aboudara M, Roller L, Rickman O, Lentz RJ, Pannu J, Chen H, Maldonado F. Improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: Initial experience with a novel adjunct. Respirology. 2020 Feb;25(2):206-213. doi: 10.1111/resp.13609. Epub 2019 Jul 2.
Styrvoky K, Schwalk A, Pham D, Madsen K, Chiu HT, Abu-Hijleh M. Radiation dose of cone beam CT combined with shape sensing robotic assisted bronchoscopy for the evaluation of pulmonary lesions: an observational single center study. J Thorac Dis. 2023 Sep 28;15(9):4836-4848. doi: 10.21037/jtd-23-587. Epub 2023 Aug 30.
Paez R, Ratwani AP, Duke JD, Bridwell G, Leonard K, Katsis JM, Pickering EM, Thiboutot J, Chen H, Chen SC, Shojaee S, Yarmus L, Lentz RJ, Maldonado F; Interventional Pulmonary Outcomes Group. Robotic versus electromagnetic bronchoscopy for pulmonary leslon assessment using integrated intraprocedural imaging: Study protocol for the reliant 2 trial. PLoS One. 2025 Dec 3;20(12):e0327611. doi: 10.1371/journal.pone.0327611. eCollection 2025.
Chen SC, Chen H, Paez R, Gatto CL, Lentz RJ, Maldonado F. A randomization strategy for a cluster-randomized controlled trial with variable operating room availability. Contemp Clin Trials. 2025 Oct;157:108057. doi: 10.1016/j.cct.2025.108057. Epub 2025 Aug 28.
First Posted
October 23, 2024
Study Start
November 11, 2024
Actual (reported)Primary Completion
October 14, 2025
Actual (reported)Study Completion
October 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 20, 2025
Record last verified: 2025-10
Individual participant data that underlie the results reported will be made available after de-identification.
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