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CT-Controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Electromagnetic Navigation Based Diagnostic Yield

NCT03355586 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-12-17

No results posted yet for this study

Summary

In this clinical trial we will investigate the diagnostic yield of a combination of commercially available imaging and navigation techniques for reaching peripheral lung lesions. The two investigated techniques will herein be the rEBUS imaging modality combined with electromagnetic based navigation. Confirmation of reaching the lung lesion will be by means of CT (fluoroscopic) imaging. Rapid On-Site Evaluation (ROSE) of cytopathology will be used for obtaining a per-procedural outcome on tissue biopsy representativeness. All data will be prospectively collected. In case tissue biopsy is found to be malignant or benign, it will be termed representative. In case tissue biopsy is found to be non-representative (=blood, anatomical lung tissue, unreachable), conventional followup of CT guided TTNA, follow-up monitoring and/or surgical biopsy will serve as golden standard for obtaining tissue diagnosis. For verification of reaching the target lesion, another study parameter of interest, (cb)CT imaging will be performed for verification that instruments are within the nodule (per-procedurally available).

Conditions

Interventions

COMBINATION_PRODUCT

Electromagnetic navigation

Electromagnetic navigation combined with use of radial EBUS probe and Rapid On Site Evaluation of Histology for diagnosis of peripheral pulmonary nodules.Controlled by cone beam CT.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Linda Garms · study coordinator

  • Erik van der Heijden, MD PhD · Pulmonary diseases

  • Roel Verhoeven, Msc · Pulmonary Diseases / Radiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2019-01-01
Completion
2019-11-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355586 on ClinicalTrials.gov