Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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.

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE November 1, 2018
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robotic Bronchoscopy for Peripheral Pulmonary Lesions
Official Title  ICMJE Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Lung; Node
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Robotic assisted bronchoscopy
Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.
Intervention: Device: Robotic assisted bronchoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2018)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03727425
Other Study ID Numbers  ICMJE 18-BR-0001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Auris Health, Inc.
Study Sponsor  ICMJE Auris Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Auris Health, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP