Clinical trial NCT04182815: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodule
Lung Cancer
Keywords: Bronchoscopy
Robotic bronchoscopy
Lung Lesions
Peripheral lesions
Lung Cancer
Monarch
Lead sponsor: Auris Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-02
Enrollment: 691
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.

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.

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 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.

Primary outcomes:
measure: Incidence of device or procedure related complications
timeFrame: up to 7 days post procedure
Secondary outcomes:
measure: Rate of device or procedure related complications
timeFrame: up to 7 days post procedure
measure: Rate of all pneumothoraxes
timeFrame: up to 7 days post procedure
measure: Total procedure time
timeFrame: During the procedure
measure: Rate of conversion to conventional bronchoscopic procedure
timeFrame: During the procedure
measure: Rate of adverse events unrelated to device or procedure
timeFrame: up to 7 days post procedure
measure: Stage at diagnosis
timeFrame: up to 24 months post procedure
measure: Diagnostic yield
timeFrame: up to 24 months post procedure
measure: Sensitivity for malignancy
timeFrame: up to 24 months post procedure
measure: Rate of post-bronchoscopy infections
timeFrame: up to 7 days post-procedure
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Encinitas
country: United States
facility: Costal Pulmonary Associates
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Farmington
country: United States
facility: The University of Connecticut Health Center
state: Connecticut
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Winfield
country: United States
facility: Northwestern Medicine Central DuPage Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Lung Center, Ltd
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America
state: Oklahoma
city: Altoona
country: United States
facility: Clinical Research Associates of Central PA
state: Pennsylvania
city: Erie
country: United States
facility: University of Pittsburgh Medical Center, Hamot
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Hong Kong
country: China
facility: Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: University of Chicago
name: Septimiu Murgu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.