Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cr… (NCT05399082) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
United States30 participantsStarted 2022-08-15
Plain-language summary
This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.
Who can participate
Age range
18 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:
\- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.
Lesion Criteria:
\- Pulmonary nodules of 8-50mm in largest dimension.
Exclusion Criteria:
* Patients with known bleeding diathesis; Platelet count \< 50,000.
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
* Inability or unwillingness to give informed consent.
* Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
* Pulmonary hypertension, defined as a right ventricular systolic pressure \> 50 mmHg.
* Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
* International Normalized Ratio (INR) \< 1.5.
* Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.
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.