Robotic Bronchoscopy for Peripheral Pulmonary Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03727425|
Recruitment Status : Completed
First Posted : November 1, 2018
Results First Posted : December 14, 2020
Last Update Posted : December 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung; Node||Device: Robotic assisted bronchoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||September 12, 2019|
|Actual Study Completion Date :||June 30, 2020|
Experimental: Robotic assisted bronchoscopy
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.
Other Name: Monarch platform
- Number of Participants With Device or Procedure Related Adverse Events [ Time Frame: 24-84 hours post-procedure ]Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
- Successful Navigation to Targeted Peripheral Pulmonary Lesions [ Time Frame: During the procedure, approximately 1 hour ]Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.
- Incidence of Complications Unrelated to Device [ Time Frame: 24-84 hours post-procedure ]Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure.
- Time to R-EBUS Confirmation (Lesion Localization) [ Time Frame: During the procedure, approximately 1 hour ]Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.
- Total Procedure Time [ Time Frame: During the procedure ]Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.
- Diagnostic Yield [ Time Frame: Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield. ]Determined from the results of the bronchoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727425
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Virginia|
|Innova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Alexander Chen, MD||Washington University School of Medicine|
|Principal Investigator:||Gerard A Silvestri, MD||Medical University of South Carolina|
|Principal Investigator:||Thomas R Gildea, MD||The Cleveland Clinic|
|Principal Investigator:||Amit K Mahajan, MD||Innova Fairfax Hospital|
|Principal Investigator:||Michael J Simoff, MD||Henry Ford Health System|