An observational study in Pulmonary Nodule and Lung Cancer, sponsored by Auris Health, Inc.. Completed at 19 sites in 3 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Auris Health, Inc. (part of Johnson & Johnson) · Observational
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.
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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 691 is above the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Auris Health, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
First submitted after Auris Health, Inc. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.
Device: Robotic assisted bronchoscopy
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Also known as: Robotic assisted bronchoscopy with Monarch platform
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.
Time frame: up to 7 days post procedure
Rate of device or procedure related complications
Individual components of the primary endpoint
Time frame: up to 7 days post procedure
Rate of all pneumothoraxes
Time frame: up to 7 days post procedure
Total procedure time
Time frame: During the procedure
Rate of conversion to conventional bronchoscopic procedure
Time frame: During the procedure
Rate of adverse events unrelated to device or procedure
Time frame: up to 7 days post procedure
Stage at diagnosis
Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer
Time frame: up to 24 months post procedure
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
Time frame: up to 24 months post procedure
Sensitivity for malignancy
Time frame: up to 24 months post procedure
Rate of post-bronchoscopy infections
Time frame: up to 7 days post-procedure
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.