Interstitial Lung Disease Clinical Trial
Official title:
Comparison of Transbronchial, Cryoprobe, and VATS Biopsy for the Diagnosis of Interstitial Lung Disease
NCT number | NCT02075762 |
Other study ID # | NA_00083791 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | December 2018 |
Verified date | January 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to compare the sample size, architectural preservation and diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) in comparison to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease (ILD).
Status | Completed |
Enrollment | 15 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Older than 18 years of age - Scheduled VATS biopsy for suspected ILD as part of standard medical care - Negative pregnancy test - Mentally capable of understanding study procedures Exclusion Criteria: - A disease or condition that interferes with safe completion of the study including: - Platelet count < 50,000 Coagulopathy defined as an International - Normalized Ratio (INR) > 1.5, or discontinuation of ticagrelor or clopidogrel within 5 days of procedure. - Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians - Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements - Concurrent participation in another study involving investigational drugs or investigational medical devices |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of biopsy technique | The number and size of all biopsies, architectural preservation of the airways/alveoli, and pathological diagnosis will be reported by the pathologist. Diagnostic yield will be calculated for each biopsy technique and compared | Data will be measured one week post procedure |
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