Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Lung; Node Clinical Trial

Official title:

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727425
• Other study ID #: 18-BR-0001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: Auris Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

Description:

Successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2020
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Capable and willing to give informed consent

2. Acceptable candidate for an elective, non-emergent bronchoscopic procedure

3. Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure

4. Lack bleeding disorders

Exclusion Criteria:

1. Medical contraindication to bronchoscopy

2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT

3. Patients with endobronchial involvement seen on chest CT

4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure

5. Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study

6. Uncontrolled or irreversible coagulopathy

7. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test

8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement

Related Conditions & MeSH terms

• Lung; Node

Intervention

Device:
• Robotic assisted bronchoscopy
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Innova Fairfax Hospital	Falls Church	Virginia
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Auris Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Device or Procedure Related Adverse Events	Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.	24-84 hours post-procedure
Primary	Successful Navigation to Targeted Peripheral Pulmonary Lesions	Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.	During the procedure, approximately 1 hour
Secondary	Incidence of Complications Unrelated to Device	Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure.	24-84 hours post-procedure
Secondary	Time to R-EBUS Confirmation (Lesion Localization)	Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.	During the procedure, approximately 1 hour
Secondary	Total Procedure Time	Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.	During the procedure
Secondary	Diagnostic Yield	Determined from the results of the bronchoscopy.	Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.