NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

Medtronic

Status: Completed

Conditions: Lung Lesion(s) Requiring Evaluation

Treatments: Procedure: Electromagnetic Navigation Bronchoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT02410837

COVENBP0475

Details and patient eligibility

About

The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

Full description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Enrollment: 1,388 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject presents with lung lesion(s) requiring evaluation
• Subject is willing and able to provide informed consent to participate in the study
• Subject is candidate for elective ENB™ procedure
• Subject is over the age of 18

Exclusion criteria

• 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

Trial design