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| ID | Type | Description | Link |
|---|---|---|---|
| EDS202101 | Other Identifier | Auris Health, Inc. |
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company strategy adjustment
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Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted Bronchoscopy | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted Bronchoscopy (Monarch Platform) | Device | Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pre-Operative
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| Name | Affiliation | Role |
|---|---|---|
| Auris Health, Inc. Clinical Trial | Auris Health, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207593 | Background | 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. | |
| 25333036 | Background | 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. |
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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
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| 29653628 | Background | 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. |
| Background | Cancer Stat Facts: Lung and Bronchus Cancer." National Cancer Institute, https://seer.cancer.gov/statfacts/html/lungb.html |
| 22045816 | Background | 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. |
| 25583767 | Background | 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. |
| 29526173 | Background | 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. |
| 2948617 | Background | 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. |
| 31805570 | Background | 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. |
| 29762461 | Background | 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. |
| 31829148 | Background | 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. |
| 32822675 | Background | 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. |
| Background | 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |