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TARGET: Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

Sponsor
Auris Health, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04182815
Collaborator
(none)
1,200
Enrollment
19
Locations
48.7
Anticipated Duration (Months)
63.2
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Condition or Disease Intervention/Treatment Phase
  • Device: Robotic assisted bronchoscopy

Detailed Description

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, 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. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.

A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
Actual Study Start Date :
Dec 10, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Robotic assisted bronchoscopy with Monarch platform

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of device or procedure related complications [up to 7 days post procedure]

      The primary endpoint is a composite that includes pneumothorax requiring intervention rated as > Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as > Grade 1 according to the CTCAE scale, and respiratory failure, rated as > Grade 3 according to the CTCAE scale.

    Secondary Outcome Measures

    1. Rate of device or procedure related complications [up to 7 days post procedure]

      Individual components of the primary endpoint

    2. Rate of all pneumothoraxes [up to 7 days post procedure]

    3. Total procedure time [During the procedure]

    4. Rate of conversion to conventional bronchoscopic procedure [During the procedure]

    5. Rate of adverse events unrelated to device or procedure [up to 7 days post procedure]

    6. Stage at diagnosis [up to 24 months post procedure]

      Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer

    7. Diagnostic yield [up to 24 months post procedure]

      Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples

    8. Sensitivity for malignancy [up to 24 months post procedure]

    9. Rate of post-bronchoscopy infections [up to 7 days post-procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Over 21 years of age;

    2. Capable and willing to give informed consent;

    3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;

    4. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy

    Exclusion Criteria:

    1. Medical contraindication to bronchoscopy as assessed by the investigator

    2. Presence of uncorrectable bleeding disorders

    3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker

    4. Patients with the target lesion having endobronchial involvement seen on chest CT

    5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,

    6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;

    7. Uncontrolled or irreversible coagulopathy;

    8. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;

    9. CT scan done greater than 28 days before the bronchoscopy procedure.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    2 Costal Pulmonary Associates Encinitas California United States 92024
    3 Eisenhower Medical Center Rancho Mirage California United States 92270
    4 The University of Connecticut Health Center Farmington Connecticut United States 06030
    5 Sarasota Memorial Hospital Sarasota Florida United States 34239
    6 University of Chicago Medicine Chicago Illinois United States 60637
    7 Northwestern Medicine Central DuPage Hospital Winfield Illinois United States 60190
    8 Franciscan Health Indianapolis Indianapolis Indiana United States 46237
    9 Spectrum Health System Grand Rapids Michigan United States 49546
    10 Minnesota Lung Center, Ltd Minneapolis Minnesota United States 55407
    11 Roswell Park Cancer Institute Buffalo New York United States 14203
    12 Cleveland Clinic Cleveland Ohio United States 931531
    13 Cancer Treatment Centers of America Tulsa Oklahoma United States 74133
    14 Clinical Research Associates of Central PA Altoona Pennsylvania United States 16602
    15 University of Pittsburgh Medical Center, Hamot Erie Pennsylvania United States 16550
    16 Medical University of South Carolina Charleston South Carolina United States 29425
    17 TriStar Centennial Medical Center Nashville Tennessee United States 37203
    18 University Health Network Toronto Ontario Canada
    19 Prince of Wales Hospital Hong Kong Hong Kong China

    Sponsors and Collaborators

    • Auris Health, Inc.

    Investigators

    • Principal Investigator: Septimiu Murgu, MD, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Auris Health, Inc.
    ClinicalTrials.gov Identifier:
    NCT04182815
    Other Study ID Numbers:
    • 19-BR-0001
    First Posted:
    Dec 2, 2019
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Auris Health, Inc.
    Bronchoscopy
    Robotic bronchoscopy
    Lung Lesions
    Peripheral lesions
    Lung Cancer
    Monarch
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules

    Study Results

    No Results Posted as of Aug 9, 2022