Status:
COMPLETED
Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Erbe USA Incorporated
Conditions:
Bronchi--Diseases
Lung Diseases, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05399082
Start Date
August 15 2022
End Date
July 11 2023
Last Update
October 17 2024
Active Locations (1)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905