Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Auris Health, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung; Node Device: Robotic assisted bronchoscopy Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Successful navigation to targeted peripheral pulmonary lesions [ Time Frame: During the procedure ]
    Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. Procedure interruptions [ Time Frame: During the procedure ]
    The sum of procedure interruptions due to platform malfunctions.

  6. 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.

  7. Diagnostic yield [ Time Frame: 24-84 hours post-procedure ]
    Determined from the results of the bronchoscopy.

  8. Conversion to conventional bronchoscopic procedure [ Time Frame: During the procedure ]
    Number of the procedure converted to the conventional bronchoscopy for any reason.



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. Capable and willing to give informed consent
  2. Acceptable candidate for an elective, non-emergent bronchoscopic procedure
  3. Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure
  4. Lack bleeding disorders

Exclusion Criteria:

  1. Medical contraindication to bronchoscopy
  2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
  3. Patients with endobronchial involvement seen on chest CT
  4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
  5. Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study
  6. Uncontrolled or irreversible coagulopathy
  7. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
  8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement

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): NCT03727425


Locations
Layout table for location information
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 Clinic
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
Sponsors and Collaborators
Auris Health, Inc.
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Auris Health, Inc.
ClinicalTrials.gov Identifier: NCT03727425     History of Changes
Other Study ID Numbers: 18-BR-0001
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Keywords provided by Auris Health, Inc.:
Bronchoscopy
Robotic bronchoscopy
Lung cancer
Peripheral lesions