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

Completed

Conditions studied: Pulmonary Nodule, Lung Cancer

In brief

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.

Key facts

Study ID

NCT04182815

Run by

Auris Health, Inc.

People needed

691

Starts

2019-12-10

Expected to finish

2023-12-15

Last updated by the study team

2025-02-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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