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 : Active, not recruiting
First Posted : November 1, 2018
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung; Node||Device: Robotic assisted bronchoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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|
|Estimated 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
- Incidence of 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 ]Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS).
- 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 ]Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.
- Time to the tissue acquisition confirmation [ Time Frame: During the procedure ]Defined by the time the robotic bronchoscope is inserted into the oropharynx until the tissue acquisition is confirmed by the rapid on site evaluation (ROSE).
- 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.
- Procedure interruptions [ Time Frame: During the procedure ]The sum of procedure interruptions due to platform malfunctions.
- Radiographic and procedural factors that influence the ability to successfully navigate to peripheral lesions [ Time Frame: During the procedure ]
Univariate and multivariate logistic regression analyses will be performed to identify factors that influence ability to successfully navigate to peripheral lesions.The following factors will be considered:
- Lesion size (recorded as the longest axis diameter)
- Lesion location (lobe)
- Presence or absence of a visible bronchus on preoperative CT san
- Procedure duration (in minutes)
- Type and amount of sedation provided
- Ability to localize peripheral lesions as confirmed by R-EBUS
- R-EBUS image characterization (concentric vs eccentric)
- Proximity of the robotic bronchoscope to peripheral lesion at the time of biopsy as measured by navigation(in millimeters)
- Distance of lesion from main carina as measured by electromagnetic navigation
- Bronchus generation count accessed by the Monarch
- Need to convert to salvage procedures
- Procedural time and total time if salvage procedure is performed.
- Diagnostic yield [ Time Frame: 24-84 hours post-procedure ]Determined from the results of the bronchoscopy.
- Conversion to conventional bronchoscopic procedure [ Time Frame: During the procedure ]Number of the procedure converted to the conventional bronchoscopy for any reason.
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|