NCT04182815Completed
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
Source: ClinicalTrials.gov · Last updated 28 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 691 (actual)
- First submitted
- 26 Nov 2019
- Start date
- 10 Dec 2019
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Auris Health, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT04182815
What you commit to
- Study type: Observational
- Participants enrolled: 691
- From 10 Dec 2019 to the primary completion date, 15 Dec 2023
- 19 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
- 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;
- CT scan done greater than 28 days before the bronchoscopy procedure.
Other illness
- Presence of uncorrectable bleeding disorders
Other
- Medical contraindication to bronchoscopy as assessed by the investigator
- Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
- Patients with the target lesion having endobronchial involvement seen on chest CT
- Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
- Uncontrolled or irreversible coagulopathy;
Who the study is looking for
- Over 21 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
| Clinical Research Associates of Central PA Coordinator of this site? Confirm its status | Altoona | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Chicago Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Costal Pulmonary Associates Coordinator of this site? Confirm its status | Encinitas | United States | Unknown status |
| University of Pittsburgh Medical Center, Hamot Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| The University of Connecticut Health Center Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| Spectrum Health System Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Franciscan Health Indianapolis Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Minnesota Lung Center, Ltd Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| TriStar Centennial Medical center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Eisenhower Medical Center Coordinator of this site? Confirm its status | Rancho Mirage | United States | Unknown status |
| Sarasota Memorial Hospital Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Cancer Treatment Centers of America Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Northwestern Medicine Central DuPage Hospital Coordinator of this site? Confirm its status | Winfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.