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

NCT ID: NCT04182815

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 691 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2023-12-15

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.

Detailed Description

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, 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. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.

A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

Conditions

Pulmonary Nodule; Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Robotic assisted bronchoscopy

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

Robotic assisted bronchoscopy

Intervention Type: DEVICE

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

Interventions

Robotic assisted bronchoscopy

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

Intervention Type: DEVICE

Other Intervention Names

Robotic assisted bronchoscopy with Monarch platform

Eligibility Criteria

Inclusion Criteria

1. Over 21 years of age;

2. Capable and willing to give informed consent;

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

4. 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

Exclusion Criteria

1. Medical contraindication to bronchoscopy as assessed by the investigator

2. Presence of uncorrectable bleeding disorders

3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker

4. Patients with the target lesion having endobronchial involvement seen on chest CT

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

6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;

7. Uncontrolled or irreversible coagulopathy;

8. 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;

9. CT scan done greater than 28 days before the bronchoscopy procedure.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auris Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Septimiu Murgu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Costal Pulmonary Associates

Encinitas, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

The University of Connecticut Health Center

Farmington, Connecticut, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

University of Chicago Medicine

Chicago, Illinois, United States

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Spectrum Health System

Grand Rapids, Michigan, United States

Minnesota Lung Center, Ltd

Minneapolis, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Cancer Treatment Centers of America

Tulsa, Oklahoma, United States

Clinical Research Associates of Central PA

Altoona, Pennsylvania, United States

University of Pittsburgh Medical Center, Hamot

Erie, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

TriStar Centennial Medical Center

Nashville, Tennessee, United States

University Health Network

Toronto, Ontario, Canada

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Countries

United States; Canada; China

References

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.

Reference Type: DERIVED

PMID: 40300665 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33590989 (View on PubMed)

Other Identifiers

19-BR-0001

Identifier Type: -

Identifier Source: org_study_id