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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04182815
Other study ID # 19-BR-0001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 10, 2019
Est. completion date December 15, 2023

Study information

Verified date February 2024
Source Auris Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 691
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada University Health Network Toronto Ontario
China Prince of Wales Hospital Hong Kong Hong Kong
United States Clinical Research Associates of Central PA Altoona Pennsylvania
United States Roswell Park Cancer Institute Buffalo New York
United States Medical University of South Carolina Charleston South Carolina
United States University of Chicago Medicine Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Costal Pulmonary Associates Encinitas California
United States University of Pittsburgh Medical Center, Hamot Erie Pennsylvania
United States The University of Connecticut Health Center Farmington Connecticut
United States Spectrum Health System Grand Rapids Michigan
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 Sarasota Memorial Hospital Sarasota Florida
United States Mayo Clinic Arizona Scottsdale Arizona
United States Cancer Treatment Centers of America Tulsa Oklahoma
United States Northwestern Medicine Central DuPage Hospital Winfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
Auris Health, Inc.

Countries where clinical trial is conducted

United States,  Canada,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of device or procedure related complications 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. up to 7 days post procedure
Secondary Rate of device or procedure related complications Individual components of the primary endpoint up to 7 days post procedure
Secondary Rate of all pneumothoraxes up to 7 days post procedure
Secondary Total procedure time During the procedure
Secondary Rate of conversion to conventional bronchoscopic procedure During the procedure
Secondary Rate of adverse events unrelated to device or procedure up to 7 days post procedure
Secondary Stage at diagnosis Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer up to 24 months post procedure
Secondary Diagnostic yield Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples up to 24 months post procedure
Secondary Sensitivity for malignancy up to 24 months post procedure
Secondary Rate of post-bronchoscopy infections up to 7 days post-procedure
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