Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Auris Robotic Endoscopy System for Bronchoscopy

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: NCT03497026
Recruitment Status : Terminated (Mutual Termination)
First Posted : April 13, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Auris Health, Inc.

Brief Summary:
In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Robotic Bronchoscopy Platform Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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).

  6. 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.

  7. 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.

  8. 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

  9. Anesthesia time [ Time Frame: During the procedure ]
    Total anesthesia time

  10. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 to 80 years of age;
  2. Capable and willing to give informed consent;
  3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
  4. Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy

Exclusion Criteria:

  1. Medical contraindication to bronchoscopy;
  2. Ground glass opacity lesions on pre-procedure CT
  3. Participation in any other clinical trial 30 days before and throughout the duration of the study;
  4. Uncontrolled or irreversible coagulopathy;
  5. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test;
  6. CT scan done over a month before the bronchoscopy procedure.

Intra-Procedure Exclusion Criteria: Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the patient's best interest.


Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
Auris Health, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Ganesh Krishna, MD El Camino Hospital

Layout table for additonal information
Responsible Party: Auris Health, Inc.
ClinicalTrials.gov Identifier: NCT03497026     History of Changes
Other Study ID Numbers: DD082015
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No