Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

NCT04182815 | Completed FDA Device

• 1 other identifier: 19-BR-0001
• Study Type: observational
• Target: 691
• Locations: 3 countries
• Sites: 19

Brief Summary

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Conditions

Pulmonary Nodule; Lung Cancer

Keywords

Bronchoscopy; Robotic bronchoscopy; Lung Lesions; Peripheral lesions; Lung Cancer; Monarch

Outcome Measures

Primary Outcomes (1)

• Incidence of device or procedure related complications

  The primary endpoint is a composite that includes pneumothorax requiring intervention rated as \> Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as \> Grade 1 according to the CTCAE scale, and respiratory failure, rated as \> Grade 3 according to the CTCAE scale.

  up to 7 days post procedure

Secondary Outcomes (9)

• Rate of device or procedure related complications

  up to 7 days post procedure

• Rate of all pneumothoraxes

  up to 7 days post procedure

• Total procedure time

  During the procedure

• Rate of conversion to conventional bronchoscopic procedure

  During the procedure

• Rate of adverse events unrelated to device or procedure

  up to 7 days post procedure

Study Arms (1)

Robotic assisted bronchoscopy

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: Robotic assisted bronchoscopy with Monarch platform

Robotic assisted bronchoscopy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.

You may qualify if:

• Over 21 years of age;
• Capable and willing to give informed consent;
• Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
• Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy

You may not qualify if:

• Medical contraindication to bronchoscopy as assessed by the investigator
• Presence of uncorrectable bleeding disorders
• Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
• Patients with the target lesion having endobronchial involvement seen on chest CT
• Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
• Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
• Uncontrolled or irreversible coagulopathy;
• Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;
• CT scan done greater than 28 days before the bronchoscopy procedure.

Sponsors & Collaborators

• Auris Health, Inc.: lead

Study Sites (19)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Costal Pulmonary Associates

Encinitas, California, 92024, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

The University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49546, United States

Location

Minnesota Lung Center, Ltd

Minneapolis, Minnesota, 55407, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14203, United States

Location

Cleveland Clinic

Cleveland, Ohio, 931531, United States

Location

Cancer Treatment Centers of America

Tulsa, Oklahoma, 74133, United States

Location

Clinical Research Associates of Central PA

Altoona, Pennsylvania, 16602, United States

Location

University of Pittsburgh Medical Center, Hamot

Erie, Pennsylvania, 16550, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

University Health Network

Toronto, Ontario, Canada

Location

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

Related Publications (2)

• Murgu S, Chen AC, Gilbert CR, Sterman DH, Pederson D, Rafeq S, Laxmanan B, Schwiers ML, Connelly J, Benz HL, Yasufuku K, Silvestri GA; TARGET Investigators. A Prospective, Multicenter Evaluation of Safety and Diagnostic Outcomes With Robotic-Assisted Bronchoscopy: Results of the Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET) Trial. Chest. 2025 Aug;168(2):539-555. doi: 10.1016/j.chest.2025.04.022. Epub 2025 Apr 27.

  PMID: 40300665 DERIVED

• Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

  PMID: 33590989 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Septimiu Murgu, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: December 10, 2019
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (17); CA (1); CN (1)