Home Health-care News Late-breaking study at CHEST 2019: The PRECISION-1 Study

Late-breaking study at CHEST 2019: The PRECISION-1 Study

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Late-breaking study: A Prospective Single-Blinded Randomized Comparative study of Three Guided Bronchoscopic Approaches for Investigating Pulmonary Nodules.


Authored by Intuitive.

Lung cancer is the leading cause of cancer-related death in the United States with low survival rates, which may be attributed to delays in diagnosis.1, 2 Bronchoscopy is a standard approach in the evaluation of patients suspected of lung cancer. Despite its wide utilization, the capabilities of bronchoscopy to support the assessment and diagnosis of pulmonary lung lesions are suboptimal.3, 4, 5

Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, launched its robotic-assisted bronchoscopy platform, the Ion Endoluminal System (www.intuitive.com/ion) in Feb 2019.6 Powered by Fiber Optic RealShape (FORS) technology, the system features an ultra-thin and ultra-maneuverable catheter that allows navigation far into the peripheral lung.7 The system’s stability enables the precision needed for biopsy.7 New developments in robotic-assisted bronchoscopy may offer improved options for assessment of peripheral lung lesion, however comparative data is not available to assess robotic-assisted bronchoscopy approach against current technologies. 

A multi-centered, prospective, single-blinded, randomized controlled comparative study was conducted to assess peripheral lung nodules with Ultrathin Bronchoscope (3.0 mm O.D.) with Radial EBUS (Olympus), electromagnetic navigation (superDimension, Medtronic) with a 6.0mm O.D. bronchoscope, and robotic bronchoscopy with a 3.5mm O.D. (Ion Endoluminal System, Intuitive.) in a human cadaver model of guided bronchoscopy for pulmonary nodules by investigators from Johns Hopkins University, Duke University, Washington University of St Louis, University of Michigan, Memorial Sloan Kettering Cancer Center, Stanford University, University of North Carolina, Vanderbilt University, and University of Pennsylvania. 

Detailed study methodology, results, and conclusion were presented by Yarmus et al. at CHEST 2019.

Title: The PRECISION-1 Study: A Prospective Single-Blinded Randomized Comparative study of Three Guided Bronchoscopic Approaches for Investigating Pulmonary Nodules.

Date: 10/23/2019

Important Safety Information
Risks associated with bronchoscopy through an endotracheal tube and under general anesthesia are infrequent and typically minor, and may include but are not limited to: sore throat, hoarseness, respiratory complications including dyspnea or hypoxemia, airway injury, bronchospasm, laryngospasm, fever, hemoptysis, chest or lung infection including pneumonia, lung abscess or an adverse reaction to anesthesia. Although rare, the following complications may also occur: bleeding, pneumothorax (collapsed lung), cardiac related complications, respiratory failure, air embolism, or death. As with other medical procedures, there may be additional risks associated with the use of general anesthesia and/or endotracheal intubation which are not listed above; you should consult a health care professional regarding these and other potential risks.

Procedures using the Ion Endoluminal System may be associated with longer procedure and/or longer anesthesia time.

Product names are trademarks or registered trademarks of Intuitive Surgical, or of their respective holders.

References:

  1. National Cancer Institute SEER stat fact sheets: lung and bronchus cancer. 2016. Available at: http://seer.cancer.gov/statfacts/html/lungb.html. Accessed March 21, 2017.
  2. Ellis PM, Vandermeer R. Delays in the diagnosis of lung cancer. J Thorac Dis. 2011;3(3):183–188. doi:10.3978/j.issn.2072-1439.2011.01.01
  3. Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest 2012; 142:385-393
  4. Ost DE, Ernst A, Lei X, et al. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med 2016; 193:68-77
  5. Gould MK, Donington J, Lynch WR, et al. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rded: American College of Chest Physicians evidence based practice guidelines. Chest. 2013;143(suppl 5): e93S–e120S.
  6. Ion is for sale in the U.S. Outside of the U.S., Ion is not CE Marked and not for human use. Ion cannot be placed on the market or put into service. Ion may not have regulatory approvals in all markets. Please check with your local Intuitive representative.
  7. Maneuverability is the ability to articulate 180° in all directions. Precision is the ability to place a biopsy tool in the desired location consistently. Stability is enabled by fiber optic RealShape (FORS) technology which maintains active robotic control of catheter position and corrects unwanted tip deflection. Results based on Intuitive internal testing.


This article was not developed by the American College of Chest Physicians (CHEST®). CHEST and its officers, regents, members, and employees disclaim all liability for the accuracy or completeness of the content and disclaim all warranties, express or implied.