A Study of Robot-Assisted Bronchoscopy in Chinese Participants With Lung Lesions
NCT ID: NCT05426213
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-07-12
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Robot-assisted Bronchoscopy
Participants with 8-50 millimeters (mm) diameter size lung lesions identified on computed tomography (CT) scan will be enrolled for robotic assisted bronchoscopy (Monarch Platform) biopsy procedure.
Robot-assisted Bronchoscopy (Monarch Platform)
Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.
Interventions
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Robot-assisted Bronchoscopy (Monarch Platform)
Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.
Eligibility Criteria
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Inclusion Criteria
* Acceptable candidate for an elective, non-emergency bronchoscopic procedure
* Lung lesions suspected of malignancy, between 8-50 millimeters (mm) in diameter size identified on thin slice (0.9-1.25 mm) computed tomography (CT) scan within 14 days, requiring bronchoscopic biopsy for diagnosis
* No more than 1 lung lesion will be targeted for robot-assisted bronchoscopy biopsy
Exclusion Criteria
* Participants with pure ground-glass opacity lesions on pre-procedure chest CT
* Participants with the target lesion having endobronchial involvement seen on chest CT
* Medical contraindications to bronchoscopy and/or anesthesia as assessed by the investigator (such as severe cardiac arrhythmias, severe hypertension, severe cardiopulmonary dysfunction, myocardial infarction, unstable angina pectoris et cetera \[etc\]) precluding safe bronchoscopic procedure
18 Years
80 Years
ALL
No
Sponsors
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Auris Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Auris Health, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Auris Health, Inc.
References
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Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
Chen W, Zheng R, Zhang S, Zhao P, Zeng H, Zou X. Report of cancer incidence and mortality in China, 2010. Ann Transl Med. 2014 Jul;2(7):61. doi: 10.3978/j.issn.2305-5839.2014.04.05.
Zeng H, Chen W, Zheng R, Zhang S, Ji JS, Zou X, Xia C, Sun K, Yang Z, Li H, Wang N, Han R, Liu S, Li H, Mu H, He Y, Xu Y, Fu Z, Zhou Y, Jiang J, Yang Y, Chen J, Wei K, Fan D, Wang J, Fu F, Zhao D, Song G, Chen J, Jiang C, Zhou X, Gu X, Jin F, Li Q, Li Y, Wu T, Yan C, Dong J, Hua Z, Baade P, Bray F, Jemal A, Yu XQ, He J. Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries. Lancet Glob Health. 2018 May;6(5):e555-e567. doi: 10.1016/S2214-109X(18)30127-X.
Cancer Stat Facts: Lung and Bronchus Cancer." National Cancer Institute, https://seer.cancer.gov/statfacts/html/lungb.html
Kramer BS, Berg CD, Aberle DR, Prorok PC. Lung cancer screening with low-dose helical CT: results from the National Lung Screening Trial (NLST). J Med Screen. 2011;18(3):109-11. doi: 10.1258/jms.2011.011055. No abstract available.
Wood DE, Kazerooni E, Baum SL, Dransfield MT, Eapen GA, Ettinger DS, Hou L, Jackman DM, Klippenstein D, Kumar R, Lackner RP, Leard LE, Leung AN, Makani SS, Massion PP, Meyers BF, Otterson GA, Peairs K, Pipavath S, Pratt-Pozo C, Reddy C, Reid ME, Rotter AJ, Sachs PB, Schabath MB, Sequist LV, Tong BC, Travis WD, Yang SC, Gregory KM, Hughes M; National comprehension cancer network. Lung cancer screening, version 1.2015: featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2015 Jan;13(1):23-34; quiz 34. doi: 10.6004/jnccn.2015.0006.
Zhou Q, Fan Y, Wang Y, Qiao Y, Wang G, Huang Y, Wang X, Wu N, Zhang G, Zheng X, Bu H, Li Y, Wei S, Chen L, Hu C, Shi Y, Sun Y. [China National Lung Cancer Screening Guideline with Low-dose Computed Tomography (2018 version)]. Zhongguo Fei Ai Za Zhi. 2018 Feb 20;21(2):67-75. doi: 10.3779/j.issn.1009-3419.2018.02.01. Chinese.
McCarty R, Plunkett LM. Binding sites for atrial natriuretic factor (ANF) in brain: alterations in Brattleboro rats. Brain Res Bull. 1986 Dec;17(6):767-72. doi: 10.1016/0361-9230(86)90088-2.
Chen AC, Pastis NJ, Machuzak MS, Gildea TR, Simoff MJ, Gillespie CT, Mahajan AK, Oh SS, Silvestri GA. Accuracy of a Robotic Endoscopic System in Cadaver Models with Simulated Tumor Targets: ACCESS Study. Respiration. 2020;99(1):56-61. doi: 10.1159/000504181. Epub 2019 Dec 5.
Rojas-Solano JR, Ugalde-Gamboa L, Machuzak M. Robotic Bronchoscopy for Diagnosis of Suspected Lung Cancer: A Feasibility Study. J Bronchology Interv Pulmonol. 2018 Jul;25(3):168-175. doi: 10.1097/LBR.0000000000000499.
Chaddha U, Kovacs SP, Manley C, Hogarth DK, Cumbo-Nacheli G, Bhavani SV, Kumar R, Shende M, Egan JP 3rd, Murgu S. Robot-assisted bronchoscopy for pulmonary lesion diagnosis: results from the initial multicenter experience. BMC Pulm Med. 2019 Dec 11;19(1):243. doi: 10.1186/s12890-019-1010-8.
Chen AC, Pastis NJ Jr, Mahajan AK, Khandhar SJ, Simoff MJ, Machuzak MS, Cicenia J, Gildea TR, Silvestri GA. Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT). Chest. 2021 Feb;159(2):845-852. doi: 10.1016/j.chest.2020.08.2047. Epub 2020 Aug 19.
Murgu S, Chen AC, Gilbert CR, Sterman DH, Pederson D, Rafeq S, Laxmanan B, Schwiers ML, Connelly J, Benz HL, Yasufuku K, Silvestri GA; TARGET Investigators. A Prospective, Multicenter Evaluation of Safety and Diagnostic Outcomes With Robotic-Assisted Bronchoscopy: Results of the Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET) Trial. Chest. 2025 Aug;168(2):539-555. doi: 10.1016/j.chest.2025.04.022. Epub 2025 Apr 27.
Other Identifiers
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EDS202101
Identifier Type: OTHER
Identifier Source: secondary_id
EDS202101
Identifier Type: -
Identifier Source: org_study_id
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