Electromagnetic Navigation for Peripheral Pulmonary Lesions

The Washington University

Status and phase: Completed; Phase 1

Conditions: Peripheral Lung Lesions

Treatments: Device: Olympus UM-S20-17S; Procedure: Biopsy; Device: Olympus BF-180 bronchoscope (standard adult); Device: Veran Spinview Thoracic Navigation System

Study type: Interventional

Funder types: Other

Identifiers

NCT02582944

201502080

Details and patient eligibility

About

Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery. The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter. This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with peripheral lung lesions 1-7cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
• Are at least 18 years old
• Are able to provide informed consent

Exclusion criteria

• Patients who refuse to participate
• Are less than 18 years of age
• Are pregnant
• Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
• Are unable to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Arm 1: Electromagnetic navigation

Experimental group

Description:

* The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed. * Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree. * Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation. * Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles.

Treatment:

Procedure: Biopsy

Device: Olympus BF-180 bronchoscope (standard adult)

Device: Veran Spinview Thoracic Navigation System

Device: Olympus UM-S20-17S