Lung Cancer Clinical Trial
— TARGETOfficial title:
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
Verified date | February 2024 |
Source | Auris Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarchâ„¢ Endoscopy Platform in a broad range of patients with pulmonary lesions.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Auris Health, Inc. |
United States, Canada, China,
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 |
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