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

Lung Cancer Clinical Trial

— TARGET  

Official title:

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182815
• Other study ID #: 19-BR-0001
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Auris Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Pulmonary Nodule

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
China	Prince of Wales Hospital	Hong Kong	Hong Kong
United States	Clinical Research Associates of Central PA	Altoona	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Costal Pulmonary Associates	Encinitas	California
United States	University of Pittsburgh Medical Center, Hamot	Erie	Pennsylvania
United States	The University of Connecticut Health Center	Farmington	Connecticut
United States	Spectrum Health System	Grand Rapids	Michigan
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
United States	Minnesota Lung Center, Ltd	Minneapolis	Minnesota
United States	TriStar Centennial Medical Center	Nashville	Tennessee
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Cancer Treatment Centers of America	Tulsa	Oklahoma
United States	Northwestern Medicine Central DuPage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Auris Health, Inc.

Countries where clinical trial is conducted

United States,  Canada,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of device or procedure related complications	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.	up to 7 days post procedure
Secondary	Rate of device or procedure related complications	Individual components of the primary endpoint	up to 7 days post procedure
Secondary	Rate of all pneumothoraxes		up to 7 days post procedure
Secondary	Total procedure time		During the procedure
Secondary	Rate of conversion to conventional bronchoscopic procedure		During the procedure
Secondary	Rate of adverse events unrelated to device or procedure		up to 7 days post procedure
Secondary	Stage at diagnosis	Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer	up to 24 months post procedure
Secondary	Diagnostic yield	Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples	up to 24 months post procedure
Secondary	Sensitivity for malignancy		up to 24 months post procedure
Secondary	Rate of post-bronchoscopy infections		up to 7 days post-procedure