superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/20/2019 |
Start Date: | August 3, 2018 |
End Date: | February 2019 |
A Post-market Feasibility Study Evaluating Location Accuracy Using the superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology in Subjects Undergoing Lung Lesion Biopsy
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™
Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
The primary objective of this post-market feasibility study is to confirm the location
accuracy of the local registration feature of the superDimension™ Navigation System Version
7.2 in subjects undergoing lung lesion biopsy.
accuracy of the local registration feature of the superDimension™ Navigation System Version
7.2 in subjects undergoing lung lesion biopsy.
Inclusion Criteria:
1. Subject presents with lung lesion(s) greater than 10 mm in diameter amenable to
evaluation by ENB at the time of evaluation
2. Lesion is intended to be biopsied by the participating investigator
3. Subject is willing and able to provide informed consent to participate in the study
4. Subject is a candidate for an elective ENB procedure
5. Subject is over the age of 18
Exclusion Criteria:
1. Central lesions that are not visible endobronchially or could be reached by a flexible
bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
2. Lesions within 10 mm of the diaphragm
3. The subject is unable or unwilling to comply with study follow-up schedule
4. The subject has participated in an investigational drug or device research study
within 30 days of enrollment that would interfere with this study
5. Female subjects who are pregnant or nursing as determined by standard site practices
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