superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
Checked against the public recordLast updated Apr 29, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Medtronic - MITG
- Interventions being studied
- Device: superDimension™ Navigation System Version 7.2
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Subject presents with lung lesion(s) 10 mm or greater 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 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- FirstHealth Moore Regional HospitalPinehurst, North Carolina
- CHI Memorial Medical GroupChattanooga, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 29, 2020. Always confirm current availability with the study team.