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In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.
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. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic assisted bronchoscopy | Experimental | Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted bronchoscopy | Device | Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device or Procedure Related Adverse Events | Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure. | 24-84 hours post-procedure |
| Successful Navigation to Targeted Peripheral Pulmonary Lesions | 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. | During the procedure, approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Complications Unrelated to Device | Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure. | 24-84 hours post-procedure |
| Time to R-EBUS Confirmation (Lesion Localization) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32822675 | Derived | Chen AC, Pastis NJ Jr, Mahajan AK, Khandhar SJ, Simoff MJ, Machuzak MS, Cicenia J, Gildea TR, Silvestri GA. Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT). Chest. 2021 Feb;159(2):845-852. doi: 10.1016/j.chest.2020.08.2047. Epub 2020 Aug 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Assisted Bronchoscopy | Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Assisted Bronchoscopy | Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Device or Procedure Related Adverse Events | Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure. | 54 patients underwent the robotic bronchoscopy procedure | Posted | Count of Participants | Participants | 24-84 hours post-procedure |
|
Adverse event data was collected from time of procedure through 84 hours post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic Assisted Bronchoscopy | Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Rehage | Auris Health, Inc. | 9256832590 | scott.rehage@aurishealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2018 | Oct 20, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS. |
| During the procedure, approximately 1 hour |
| Total Procedure Time | Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed. | During the procedure |
| Diagnostic Yield | Determined from the results of the bronchoscopy. | Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield. |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Innova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Successful Navigation to Targeted Peripheral Pulmonary Lesions | 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. | Radial probe endobronchial ultrasound was available in 53/54 cases. | Posted | Count of Participants | Participants | During the procedure, approximately 1 hour |
|
|
|
| Secondary | Incidence of Complications Unrelated to Device | Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure. | 54 patients underwent the robotic bronchoscopy procedure | Posted | Count of Participants | Participants | 24-84 hours post-procedure |
|
|
|
| Secondary | Time to R-EBUS Confirmation (Lesion Localization) | Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS. | Radial probe endobronchial ultrasound was available in 53/54 cases. | Posted | Mean | Inter-Quartile Range | Minutes | During the procedure, approximately 1 hour |
|
|
|
| Secondary | Total Procedure Time | Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed. | 54 patients underwent the robotic bronchoscopy procedure | Posted | Mean | Inter-Quartile Range | Minutes | During the procedure |
|
|
|
| Secondary | Diagnostic Yield | Determined from the results of the bronchoscopy. | 54 patients underwent the robotic bronchoscopy procedure | Posted | Count of Participants | Participants | Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield. |
|
|
|
| 0 |
| 55 |
| 2 |
| 55 |
| 0 |
| 55 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |