Lung Cancer Clinical Trial
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
Summary
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarchâ„¢ Endoscopy Platform in a broad range of patients with pulmonary lesions.
Full Description
Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.
A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarchâ„¢ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.
Eligibility Criteria
Inclusion Criteria:
Over 21 years of age;
Capable and willing to give informed consent;
Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy
Exclusion Criteria:
Medical contraindication to bronchoscopy as assessed by the investigator
Presence of uncorrectable bleeding disorders
Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
Patients with the target lesion having endobronchial involvement seen on chest CT
Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
Uncontrolled or irreversible coagulopathy;
Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;
CT scan done greater than 28 days before the bronchoscopy procedure.
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There are 17 Locations for this study
Scottsdale Arizona, 85259, United States More Info
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Principal Investigator
Encinitas California, 92024, United States
Rancho Mirage California, 92270, United States More Info
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Farmington Connecticut, 06030, United States More Info
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Sarasota Florida, 34239, United States More Info
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Chicago Illinois, 60637, United States More Info
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Winfield Illinois, 60190, United States More Info
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Indianapolis Indiana, 46237, United States More Info
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Grand Rapids Michigan, 49546, United States More Info
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Minneapolis Minnesota, 55407, United States More Info
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Buffalo New York, 14203, United States
Cleveland Ohio, 93153, United States
Tulsa Oklahoma, 74133, United States
Altoona Pennsylvania, 16602, United States More Info
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Principal Investigator
Erie Pennsylvania, 16550, United States More Info
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Principal Investigator
Charleston South Carolina, 29425, United States More Info
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Principal Investigator
Nashville Tennessee, 37203, United States More Info
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Principal Investigator
Toronto Ontario, , Canada
Hong Kong Hong Kong, , China
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