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Clinical Trials
National Lung Screening Trial
Main Objective: To determine whether lung cancer screening using low-dose helical CT reduces lung cancer-specific mortality relative to screening with chest radiographs in a high-risk cohort.
Study Design Summary: Prior to randomization, standardized eligibility, health, sociodemographic, and spirometry will be performed. Some participants will provide blood, sputum and urine samples for archive at study entry and at the time of the second incidence screen. Study participants will be randomized into an Experimental and a Control group. The Experimental group will undergo screening with low dose helical CT. The Control group will undergo screening with chest radiographs. Both groups will be screened annually for at least two incidence screens. Both groups will be contacted at six-month intervals to document interval health status. This protocol is conducted in close coordination with the Lung Screening Study of NCI. The two studies comprise the National Lung Screening Trial (NLST).
Participants: Current or former cigarette smokers between the ages of 55 and 74 years without a history of lung cancer.
Emphaysys Endobronchial V alve for E mphysema Palliatio N T rial ( VENT ) Trial
Main Objective: The VENT research study is being conducted to assess the safety and efficacy of the Emphasys Endobronchial Valve*. Patients will be randomized to receive either standard optimal medical management (with pulmonary rehabilitation) (control group) or the Emphasys Endobronchial Valve and procedure (with pulmonary rehabilitation) (treatment group).
Study Design Summary: The Emphasys endobronchial valve procedure is performed bronchoscopically under routine anesthesia using the Zephyr EBV endobronchial valve implantable device.
Participants: Patients with heterogeneous emphysema who meet the eligibility (inclusion/exclusion) criteria outlined by the study protocol.
AIR2 Trial
Main Objective: To study the safety and effectiveness of a new investigational outpatient procedure called BronchialThermoplastyT for the treatment of severe refractory asthma.
Study Design Summary: This randomized, double blind, sham-controlled study is aimed to demonstrate the safety and effectiveness of the Alair ? System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids (ICS - doses greater than 1000µg per day Beclomethasone or equivalent) and long-acting ß2-agonists (LABA - doses of at least 100µg per day Salmeterol or equivalent). The Alair System is a used to administer a non drug outpatient procedure that requires no incision and has been shown to reduce airway hyperresponsiveness in prior animal and human studies.
Participants: Individuals age 18 to 65 with severe asthma who meet the eligibility (inclusion/exclusion) criteria outlined by the study protocol.
The Utilization of MNS (Magnetic Navigation System) in Bronchoscopy
Main Objective: To show using a magnetic navigation system provides safety and will improve catheter mobility and directionality while providing greater maneuverability. This increase in mobility should improve the operators ability to reach distal bronchial tissue and increase diagnostic yield.
Study Design Summary: We wish to apply the MNS concept to 10 abnormal subjects with CT confirmed 1.5 cm or greater pulmonary nodules and provide evidence for human safety and bronchial catheter target acquisition. Up to two pre-selected bronchial targets (pulmonary nodules) will be made. A special designed endobronchial catheter will be used under control of a magnetic field. Direct bronchoscopic visualization of magnetic guided catheter movement will be observed in the trachea and main bronchial airways. At no time during this study will tissue biopsies be taken. The NIOBE ä magnetic guidance system (Stereotaxis, Inc.) will be used at our institution.
Participants: These individuals will have chest CT evidence of one or more pulmonary nodules greater than 1.5 cm in diameter. Be willing to undergo a study bronchoscopy.
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