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

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 : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Auris Health, Inc.

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
Pulmonary Nodule Lung Cancer 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.

Layout table for study information
Study Type : Observational
Estimated 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 : December 10, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort 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 Name: Robotic assisted bronchoscopy with Monarch platform




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rate of device or procedure related complications [ Time Frame: up to 7 days post procedure ]
    Individual components of the primary endpoint

  2. Rate of all pneumothoraxes [ Time Frame: up to 7 days post procedure ]
  3. Total procedure time [ Time Frame: During the procedure ]
  4. Rate of conversion to conventional bronchoscopic procedure [ Time Frame: During the procedure ]
  5. Rate of adverse events unrelated to device or procedure [ Time Frame: up to 7 days post procedure ]
  6. 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

  7. 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

  8. Sensitivity for malignancy [ Time Frame: up to 24 months post procedure ]
  9. Specificity [ Time Frame: up to 24 months post procedure ]
  10. Positive predictive value [ Time Frame: up to 24 months post procedure ]
  11. Negative predictive value [ Time Frame: up to 24 months post procedure ]
  12. Rate of post-bronchoscopy infections [ Time Frame: up to 7 days post-procedure ]


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:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.
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.

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): NCT04182815


Contacts
Layout table for location contacts
Contact: Scott Rehage 6508370301 ext 6508370301 scott.rehage@aurishealth.com
Contact: Emir Deljkich 6503972677 ext 6503972677 emir.deljkich@aurisrobotics.com

Locations
Layout table for location information
United States, Florida
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Mary Bradley         
Principal Investigator: Paul Chomiak, MD         
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Candace Murphy         
Principal Investigator: Septimiu Murgu, MD         
United States, Minnesota
Minnesota Lung Center, Ltd Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Buffi Moss         
Principal Investigator: Jonathan T Hovda, MD         
United States, Oklahoma
Cancer Treatment Centers of America Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Faye Biggs         
Principal Investigator: Daniel Nader, DO         
United States, Pennsylvania
Clinical Research Associates of Central PA Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Shari Edevane         
Principal Investigator: Sandeep Bansal, MD         
University of Pittsburgh Medical Center, Hamot Recruiting
Erie, Pennsylvania, United States, 16550
Contact: Patty Henry         
Principal Investigator: Christopher Lau, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Abby Wenzel         
Principal Investigator: Nicholas Pastis, MD         
Sponsors and Collaborators
Auris Health, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Septimiu Murgu, MD University of Chicago
Layout table for additonal information
Responsible Party: Auris Health, Inc.
ClinicalTrials.gov Identifier: NCT04182815    
Other Study ID Numbers: 19-BR-0001
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
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
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:
Layout table for MeSH terms
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases