Robotic Bronchoscopy for Peripheral Pulmonary Lesions

NCT03727425 | Completed Results FDA Device

• 1 other identifier: 18-BR-0001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung; Node

Keywords

Bronchoscopy; Robotic bronchoscopy; Lung cancer; Peripheral lesions

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Incidence of Complications Unrelated to Device

  24-84 hours post-procedure

• Time to R-EBUS Confirmation (Lesion Localization)

  During the procedure, approximately 1 hour

• Total Procedure Time

  During the procedure

• Diagnostic Yield

  Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.

Study Arms (1)

Robotic assisted bronchoscopy

EXPERIMENTAL

Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Device: Robotic assisted bronchoscopy

Interventions

Robotic assisted bronchoscopy DEVICE

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

Also known as: Monarch platform

Robotic assisted bronchoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable and willing to give informed consent
• Acceptable candidate for an elective, non-emergent bronchoscopic procedure
• 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
• Lack bleeding disorders

You may not qualify if:

• Medical contraindication to bronchoscopy
• Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
• Patients with endobronchial involvement seen on chest CT
• Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
• Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study
• Uncontrolled or irreversible coagulopathy
• Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
• Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement

Sponsors & Collaborators

• Auris Health, Inc.: lead

Study Sites (5)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Innova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (1)

• 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.

  PMID: 32822675 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Scott Rehage
• Organization: Auris Health, Inc.

scott.rehage@aurishealth.com

9256832590

Study Officials

• Alexander Chen, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Gerard A Silvestri, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Thomas R Gildea, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Amit K Mahajan, MD

  Innova Fairfax Hospital

  PRINCIPAL INVESTIGATOR

• Michael J Simoff, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 1, 2018
• Study Start: November 1, 2018
• Primary Completion: September 12, 2019
• Study Completion: June 30, 2020
• Last Updated: December 14, 2020
• Results First Posted: December 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)