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

Overview

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.

Full Title of Study: “Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2023

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.

Interventions

  • Device: Robotic assisted bronchoscopy
    • Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Arms, Groups and Cohorts

  • Other: Robotic assisted bronchoscopy
    • Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of device or procedure related complications
    • Time Frame: 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 Measures

  • Rate of device or procedure related complications
    • Time Frame: up to 7 days post procedure
    • Individual components of the primary endpoint
  • Rate of all pneumothoraxes
    • Time Frame: up to 7 days post procedure
  • Total procedure time
    • Time Frame: During the procedure
  • Rate of conversion to conventional bronchoscopic procedure
    • Time Frame: During the procedure
  • Rate of adverse events unrelated to device or procedure
    • Time Frame: up to 7 days post procedure
  • Stage at diagnosis
    • Time Frame: 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
  • Diagnostic yield
    • Time Frame: 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
  • Sensitivity for malignancy
    • Time Frame: up to 24 months post procedure
  • Specificity
    • Time Frame: up to 24 months post procedure
  • Positive predictive value
    • Time Frame: up to 24 months post procedure
  • Negative predictive value
    • Time Frame: up to 24 months post procedure
  • Rate of post-bronchoscopy infections
    • Time Frame: up to 7 days post-procedure

Participating in This Clinical Trial

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 14 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 14 days before the bronchoscopy procedure.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Auris Health, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Septimiu Murgu, MD, Principal Investigator, University of Chicago
  • Overall Contact(s)
    • Scott Rehage, 6508370301, scott.rehage@aurishealth.com

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