Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (NCT04486560) | Clinical Trial Compass
CompletedNot Applicable
Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
United States51 participantsStarted 2020-07-07
Plain-language 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 bronchoscopic approach.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or Female, ≥ 18-years-old
* Scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical care determined by their treating pulmonologist
Exclusion Criteria:
* 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
What they're measuring
1
Number of Participants With Serious Adverse Events