NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
Phase: Post-market Global Observational Study
Status: Not Recruiting
This is an observational study to evaluate outcomes following Electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system. ENB is like a GPS for airways with an image-guided approach that uses 3D-reconstructed computed tomography (CT)-scan and sensor location technology. It helps to guide a steerable endoscopic probe to reach targets in lungs, such as peripheral lung lesions that may be beyond the reach of conventional bronchoscopes. The approach may help with accurate diagnosing of suspicious lesions in people with lung disease so they can obtain personalized treatments. Subjects will be asked to participate in a clinical research study if they are scheduled, as part of their normal care, to have an ENB™ procedure. This procedure is not experimental, is approved by the Food and Drug Administration (FDA), and the product is commercially available. The collected study data may help the sponsor to establish additional data on this device for the diagnosis and treatment of lung lesions.
For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.