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Brief Title: Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
Official Title: Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
Study ID: NCT04182815
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.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Septimiu Murgu, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR