Lung Cancer Clinical Trial

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

Summary

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

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Full 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 Monarchâ„¢ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Lung Cancer

Estimated Enrollment:

1200

Study ID:

NCT04182815

Recruitment Status:

Recruiting

Sponsor:

Auris Health, Inc.

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There are 17 Locations for this study

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Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States More Info
Alex Galvez
Contact
Karen Swanson, DO
Principal Investigator
Costal Pulmonary Associates
Encinitas California, 92024, United States
Eisenhower Medical Center
Rancho Mirage California, 92270, United States More Info
Debra Bright
Contact
Justin Thomas, MD
Principal Investigator
The University of Connecticut Health Center
Farmington Connecticut, 06030, United States More Info
Catlin Webb
Contact
Omar Ibrahim, MD
Principal Investigator
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States More Info
Kristen McKenzie
Contact
Paul Chomiak, MD
Principal Investigator
University of Chicago Medicine
Chicago Illinois, 60637, United States More Info
Spring Maleckar
Contact
Septimiu Murgu, MD
Principal Investigator
Northwestern Medicine Central DuPage Hospital
Winfield Illinois, 60190, United States More Info
Sarah Madia
Contact
Benjamin J Seides, MD
Principal Investigator
Franciscan Health Indianapolis
Indianapolis Indiana, 46237, United States More Info
Abby Ertel
Contact
Faisal Khan, MD
Principal Investigator
Spectrum Health System
Grand Rapids Michigan, 49546, United States More Info
Stephanie Mueller
Contact
Gustavo Cumbo-Nacheli, MD
Principal Investigator
Minnesota Lung Center, Ltd
Minneapolis Minnesota, 55407, United States More Info
Doug Flashinski
Contact
Jonathan T Hovda, MD
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14203, United States
Cleveland Clinic
Cleveland Ohio, 93153, United States
Cancer Treatment Centers of America
Tulsa Oklahoma, 74133, United States
Clinical Research Associates of Central PA
Altoona Pennsylvania, 16602, United States More Info
Shari Edevane
Contact
Sandeep Bansal, MD
Principal Investigator
University of Pittsburgh Medical Center, Hamot
Erie Pennsylvania, 16550, United States More Info
Patty Henry
Contact
Christopher Lau, MD
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Abby Wenzel
Contact
Nicholas Pastis, MD
Principal Investigator
TriStar Centennial Medical Center
Nashville Tennessee, 37203, United States More Info
Hailey Hank
Contact
Susan Garwood, MD
Principal Investigator
University Health Network
Toronto Ontario, , Canada
Prince of Wales Hospital
Hong Kong Hong Kong, , China

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

1200

Study ID:

NCT04182815

Recruitment Status:

Recruiting

Sponsor:


Auris Health, Inc.

How clear is this clinincal trial information?

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