Auris Robotic Endoscopy System for Bronchoscopy
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|ClinicalTrials.gov Identifier: NCT03497026|
Recruitment Status : Terminated (Mutual Termination)
First Posted : April 13, 2018
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: Robotic Bronchoscopy Platform||Not Applicable|
The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varying technologies have been proposed to guide endobronchial biopsies, such as electromagnetic navigation, endobronchial ultrasound (EBUS) and computed tomography fluoroscopy. However, the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is critical to biopsy success.
In this study , the novel Robotic Endoscopy Platform and its accessories will be used to provide bronchoscopic visualization of and access to patient airways for diagnostic procedures. Commercially available biopsy instruments will be used to acquire tissue for diagnostic purposes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures|
|Actual Study Start Date :||March 30, 2018|
|Actual Primary Completion Date :||July 10, 2018|
|Actual Study Completion Date :||July 10, 2018|
Experimental: Robotic Bronchoscopy
Robotic bronchoscopy with Robotic Bronchoscopy Platform
Device: Robotic Bronchoscopy Platform
Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Other Name: The Monarch Platform
- Completion of the intended bronchoscopic procedure with the Robotic Endoscopy Platform [ Time Frame: During the procedure ]Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.
- Incidence of device or procedure related Adverse Events [ Time Frame: 6 weeks ]Calculate from the rate between number of patients with device or procedure related adverse events and number of patients who underwent the robotic bronchoscopy procedure.
- Identification of correct bronchi leading to the targeted lesions [ Time Frame: During the procedure ]The principal investigator will assess the capabilities of the navigation to identify optimal path to the targeted lesion.
- Ability to localize targeted lesion [ Time Frame: During the procedure ]Radial probe endobronchial ultrasound will be used in all cases to confirm the presence of a lesion immediately before performing biopsy.
- Alignment capabilities [ Time Frame: During the procedure ]Calculate from the sum of results that were positive for the first attempt of tissue acquisition divided by the sum of all attempts.
- Time to REBUS confirmation [ 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 ]Total procedure time is defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.
- Diagnostic yield [ Time Frame: 6 weeks ]Calculate from the sum of results that were diagnostically positive for malignancy and the sum of the results that were diagnostically negative for malignancy based o n the sum of all targets.
- Conversion to conventional bronchoscopic procedure [ Time Frame: During the procedure ]Calculate from the rate between number of procedures with robotic bronchoscope and number of procedures converted to conventional bronchoscopy
- Anesthesia time [ Time Frame: During the procedure ]Total anesthesia time
- Incidence of complications unrelated to device [ Time Frame: 6 weeks ]Calculate from the rate between number of patients with complications unrelated to device and number of patients who underwent the robotic bronchoscopy procedure.
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): NCT03497026
|United States, California|
|El Camino Hospital|
|Mountain View, California, United States, 94040|
|Palo Alto Medical Foundation Mountain View Center|
|Mountain View, California, United States, 94040|
|Principal Investigator:||Ganesh Krishna, MD||El Camino Hospital|