Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
- Conditions
- Pulmonary NoduleLung Cancer
- Interventions
- Device: Robotic assisted bronchoscopy
- Registration Number
- NCT04182815
- Lead Sponsor
- Auris Health, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 691
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Robotic assisted bronchoscopy Robotic assisted bronchoscopy Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.
- Primary Outcome Measures
Name Time Method Incidence of device or procedure related complications up to 7 days post procedure 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.
- Secondary Outcome Measures
Name Time Method Total procedure time During the procedure Rate of conversion to conventional bronchoscopic procedure During the procedure Rate of device or procedure related complications up to 7 days post procedure Individual components of the primary endpoint
Sensitivity for malignancy up to 24 months post procedure Rate of post-bronchoscopy infections up to 7 days post-procedure Rate of adverse events unrelated to device or procedure up to 7 days post procedure Rate of all pneumothoraxes up to 7 days post procedure Stage at diagnosis up to 24 months post procedure Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer
Diagnostic yield up to 24 months post procedure Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples
Trial Locations
- Locations (19)
University Health Network
🇨🇦Toronto, Ontario, Canada
The University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Franciscan Health Indianapolis
🇺🇸Indianapolis, Indiana, United States
Minnesota Lung Center, Ltd
🇺🇸Minneapolis, Minnesota, United States
TriStar Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Costal Pulmonary Associates
🇺🇸Encinitas, California, 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
Spectrum Health System
🇺🇸Grand Rapids, Michigan, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Clinical Research Associates of Central PA
🇺🇸Altoona, Pennsylvania, United States
University of Pittsburgh Medical Center, Hamot
🇺🇸Erie, Pennsylvania, United States
Prince of Wales Hospital
🇨🇳Hong Kong, Hong Kong, China
Cancer Treatment Centers of America
🇺🇸Tulsa, Oklahoma, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States