A Study of Robot-Assisted Bronchoscopy in Chinese Participants With Lung Lesions

A Real-World Study to Evaluate the Effectiveness and Safety of Robot-Assisted Bronchoscopy in Chinese Patients With Lung Lesions

Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.

Study Overview

• Status: Withdrawn
• Conditions: Lung Neoplasms
• Intervention / Treatment: Device: Robot-assisted Bronchoscopy (Monarch Platform)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 571434
      • Hainan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Capable and willing to give informed consent
• 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:

Pre-Operative

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Robot-assisted Bronchoscopy (Monarch Platform); Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Navigation Success Rate	Navigation success rate is defined as the percentage of successful navigation to the targeted lung lesion (lesion localization) as confirmed by radial probe endobronchial ultrasound (R-EBUS) imaging through Monarch Platform during bronchoscopy procedure.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to R-EBUS Confirmation	Time to R-EBUS confirmation is defined by the time from the robotic bronchoscope inserted into the oropharynx to the localization of the targeted lesion confirmed by R-EBUS.	Intraoperative
Time to the Tissue Acquisition	Time to the tissue acquisition is defined by the time the robotic bronchoscope is inserted into the oropharynx until the tissue acquisition is confirmed by the Rapid On-site evaluation (ROSE).	Intraoperative
Total Procedure Time	Total procedure time is defined by the time the robotic bronchoscope is inserted into the oropharynx until the robotic bronchoscope is removed.	Intraoperative
Number of Conversion to Conventional Bronchoscopic Procedure	Number of conversion to conventional bronchoscopic procedure is defined as the number of procedures converted to other diagnostic modality due to inability of the Monarch platform to complete the intended bronchoscopy.	Intraoperative
Number of Participants with Pneumothorax Requiring Intervention	Number of participants with pneumothorax requiring intervention (rated as greater than [>] Grade 1 according to the Common Terminology Criteria for Adverse Events [CTCAE] scale) will be reported.	Up to 7 days post procedure
Number of Participants with Device or Procedure Related Bleeding Requiring Medical Intervention	Number of participants with device or procedure related bleeding requiring medical intervention (rated as >Grade 1 according to the CTCAE scale) will be reported.	Up to 7 days post procedure
Number of Participants with Device or Procedure Related Respiratory Failure	Number of participants with device or procedure related respiratory failure (rated as >Grade 3 according to the CTCAE scale) will be reported.	Up to 7 days post procedure

Collaborators and Investigators

• Sponsor: Auris Health, Inc.
• Investigators: Study Director: Auris Health, Inc. Clinical Trial, Auris Health, Inc.

Publications and helpful links

General Publications

• 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. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
• 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.
• Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET study) https://clinicaltrials.gov/ct2/show/NCT04182815?term=04182815&draw=2&rank=1

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): September 15, 2023
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: EDS202101 (Other Identifier: Auris Health, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes