Pinehurst, North Carolina 28374


Purpose:

The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03585959


Primary Contact:

Principal Investigator
Michael A. Pritchett, DO MPH
FirstHealth Moore Regional Hospital

Sean Pidgeon
Phone: (781) 460-1553
Email: sean.p.pidgeon@medtronic.com


Backup Contact:

Email: nichole.j.nielsen@medtronic.com
Nichole Nielsen
Phone: (763) 398-7656


Location Contact:

Pinehurst, North Carolina 28374
United States

Michael Pritchett, D.O.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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