Status:
COMPLETED
Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Erbe USA Incorporated
Conditions:
Lung Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and collect data on the initial effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for transbronchial lung biopsy via a bro...
Detailed Description
A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality ...
Eligibility Criteria
Inclusion
- Male or Female, ≥ 18-years-old
- Scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical care determined by their treating pulmonologist
Exclusion
- Pregnant or nursing females, or females of child bearing potential who refuse to take a pregnancy test prior to enrollment
- Individuals with current or recent systematic conditions, such as uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 110 mmHg), type 1 diabetes, severe pulmonary hypertension, acute kidney injury, stroke (within the last 6 months) or myocardial infarction (within the last 3 months)
- Presence of bleeding disorder
- 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)
- International Normalized Ratio (INR) \<1.5
- Robotic Bronchoscopy
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04486560
Start Date
July 7 2020
End Date
January 31 2022
Last Update
February 25 2022
Active Locations (2)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232