Clinical trial NCT03727425: Robotic Bronchoscopy for Peripheral Pulmonary Lesions
Official title: Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung; Node
Keywords: Bronchoscopy
Robotic bronchoscopy
Lung cancer
Peripheral lesions
Lead sponsor: Auris Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Device or Procedure Related Adverse Events
timeFrame: 24-84 hours post-procedure
measure: Successful Navigation to Targeted Peripheral Pulmonary Lesions
timeFrame: During the procedure, approximately 1 hour
Secondary outcomes:
measure: Incidence of Complications Unrelated to Device
timeFrame: 24-84 hours post-procedure
measure: Time to R-EBUS Confirmation (Lesion Localization)
timeFrame: During the procedure, approximately 1 hour
measure: Total Procedure Time
timeFrame: During the procedure
measure: Diagnostic Yield
timeFrame: Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Falls Church
country: United States
facility: Innova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Washington University School of Medicine
name: Alexander Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Gerard A Silvestri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Thomas R Gildea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innova Fairfax Hospital
name: Amit K Mahajan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health System
name: Michael J Simoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen AC, Pastis NJ Jr, Mahajan AK, Khandhar SJ, Simoff MJ, Machuzak MS, Cicenia J, Gildea TR, Silvestri GA. Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT). Chest. 2021 Feb;159(2):845-852. doi: 10.1016/j.chest.2020.08.2047. Epub 2020 Aug 19.