superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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

Key facts

Study ID

NCT03585959

Run by

Medtronic - MITG

People needed

50

Starts

2018-08-03

Expected to finish

2019-02-18

Last updated by the study team

2020-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• FirstHealth Moore Regional Hospital — Pinehurst, North Carolina, United States
• CHI Memorial Medical Group — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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