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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05426213
• Other study ID #: EDS202101
• Secondary ID: EDS202101
• Status: Withdrawn
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Auris Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Device:
• Robot-assisted Bronchoscopy (Monarch Platform)
Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.

Locations

Country	Name	City	State
China	Hainan General Hospital	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Auris Health, Inc.

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View Citation

Cancer Stat Facts: Lung and Bronchus Cancer." National Cancer Institute, https://seer.cancer.gov/statfacts/html/lungb.html

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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