superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology

Study summary

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

Ask AI to explain this study

Start here

Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedsuperDimension™ Navigation System Version 7.2

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 29, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Medtronic - MITG

Study sponsor

Study overview

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

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

View original record ↗