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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182815
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Auris Health, Inc.

Tracking Information
First Submitted Date November 26, 2019
First Posted Date December 2, 2019
Last Update Posted Date September 3, 2020
Actual Study Start Date December 10, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 27, 2019)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
Official Title Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.
Condition
  • Pulmonary Nodule
  • Lung Cancer
Intervention Device: Robotic assisted bronchoscopy
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Other Name: Robotic assisted bronchoscopy with Monarch platform
Study Groups/Cohorts 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 Recruiting
Estimated Enrollment
 (submitted: November 27, 2019)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Scott Rehage 9256832590 scott.rehage@aurishealth.com
Contact: Jaime Connelly 5132848104 JConnel8@its.jnj.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04182815
Other Study ID Numbers 19-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
Plan to Share IPD: No
Responsible Party Auris Health, Inc.
Study Sponsor Auris Health, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Septimiu Murgu, MD University of Chicago
PRS Account Auris Health, Inc.
Verification Date September 2020