Peripheral Lung Lesions
Conditions
Brief summary
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.
Interventions
DEVICEOlympus BF-180 bronchoscope (standard adult)
-Standard of care
DEVICEVeran Spinview Thoracic Navigation System
-Electromagnetic navigation
DEVICEOlympus UM-S20-17S
-Endobronchial ultrasound mini-probe
PROCEDUREBiopsy
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance | At the time of procedure (1 day) | -Primary outcome of diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of successful navigation by using radial probe endobronchial ultrasound | At the time of procedure (1 day) | — |
| Safety as measured by adverse event rates | At the time of procedure (1 day) | -Pneumothorax will be documented by post-biopsy CXR or chest ultrasonography, and the number requiring intervention, such as chest tube placement, will be recorded. Significant hemoptysis will be defined as bleeding noted at the time of procedure that requires a change in the level of care (e.g. outpatient to inpatient or inpatient to ICU) or a blood transfusion. Other adverse events that are common to bronchoscopy will be monitored |
Countries
United States
Outcome results
None listed