Electromagnetic Navigation for Peripheral Pulmonary Lesions

Peripheral Lung Lesions Clinical Trial

Official title:

Electromagnetic Navigation for Peripheral Pulmonary Lesions Using a Tip Tracked Steerable Catheter and Optical Guidance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582944
• Other study ID #: 201502080
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2015
• Last updated: December 21, 2017
• Start date: March 25, 2015
• Est. completion date: May 19, 2017

Study information

• Verified date: December 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Lung Lesions

Intervention

Device:
• Olympus BF-180 bronchoscope (standard adult)
-Standard of care
• Veran Spinview Thoracic Navigation System
-Electromagnetic navigation
• Olympus UM-S20-17S
-Endobronchial ultrasound mini-probe

Procedure:
• Biopsy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance	-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.	At the time of procedure (1 day)
Secondary	Confirmation of successful navigation by using radial probe endobronchial ultrasound		At the time of procedure (1 day)
Secondary	Safety as measured by adverse event rates	-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	At the time of procedure (1 day)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine