Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (NCT04182815) | Clinical Trial Compass
CompletedNot Applicable
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
United States, Canada, China691 participantsStarted 2019-12-10
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Medical contraindication to bronchoscopy as assessed by the investigator
. Presence of uncorrectable bleeding disorders
. 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
. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of device or procedure related complications
. 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;