Lung Cancer Clinical Trial
superDimensionâ„¢ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
Summary
The purpose of this investigation is to confirm the clinical accuracy of the superDimensionâ„¢ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
Full Description
The primary objective of this post-market feasibility study is to confirm the location accuracy of the local registration feature of the superDimensionâ„¢ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.
Eligibility Criteria
Inclusion Criteria:
Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation
Lesion is intended to be biopsied by the participating investigator
Subject is willing and able to provide informed consent to participate in the study
Subject is a candidate for an elective ENB procedure
Subject is over the age of 18
Exclusion Criteria:
Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
Lesions within 10 mm of the diaphragm
The subject is unable or unwilling to comply with study follow-up schedule
The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
Female subjects who are pregnant or nursing as determined by standard site practices
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There are 2 Locations for this study
Pinehurst North Carolina, 28374, United States
Chattanooga Tennessee, 37404, United States
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