Chronic Obstructive Pulmonary Disease (COPD)
COMPLETE-1 Study
Pilot randomized control trial evaluating the feasibility and effectiveness of performing a combined endobronchial valve placement and video-assisted thoracic surgery fissure completion procedure in severe emphysema patients with incomplete lobar fissures
WHOPatients with severe emphysema (FEV1 ≥15% or ≤ 45% of predicted), Not smoking for 4 months, Age 40- 75 years old, Incomplete lobar fissures (<95% fissure integrity)
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WHATPilot randomized controlled trial for combined VATS fissure completion and EBVs placement, Lobar fissure completion adjacent to target lobe for bronchoscopic lung volume reduction with EBVs
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HOWLobar fissure completion using a surgical stapler via VATS to address collateral ventilation between the target and adjacent lobes. Subsequent EBVs placement during the same procedure for target lung volume reduction
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SAVED-1 Study
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction (SAVED-1)
WHOPatients with severe emphysema who underwent bronchoscopic lung volume reduction, but did not demonstrate target lung volume reduction (TLVR>350mL) or symptom improvement (mMRC>2)
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WHATPilot cohort study for lobar fissure completion and pleural adhesiolysis after a failed bronchoscopic lung volume reduction with EBVs
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HOWLobar fissure completion using a surgical stapler and pleural adhesiolysis via VATS or RATS to address collateral ventilation between the target and adjacent lobes and release the target lobe from the chest wall.
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RheSolve Study
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD
WHOPatient has chronic bronchitis, Patient has an FEV1/FVC < 0.7, Age 35 or older, Not smoking for 6 months, Patient has a CAT score ≥10 (first two questions sum to ≥7 points)
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WHATRandomized, double-blind, controlled trial for two outpatient bronchoscopic treatments of patients with moderate to severe chronic bronchitis. Possibility to crossover to the treatment group after 12 months.
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HOWAblation of the goblet and other hypersecretory cells of the airway epithelium and mucosa with the RheOx system via bronchoscopy.
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SPRAY-CB Study
A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis
WHOPatient has chronic bronchitis, Moderate to severe COPD (>30% FEV1 to <80%), Not smoking for 2 months, Age 40- 80 years old One severe or two moderate COPD exacerbations in the past year
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WHATRandomized, double-blind, controlled trial for two outpatient bronchoscopic treatments of patients with moderate to severe chronic bronchitis. Possibility to crossover to the treatment group after 12 months
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HOWBronchoscopic application of metered cryogen spray which flash freeze the surface area of damaged airways. Diseased cells are destroyed, leaving behind the extra-cellular structure that allows for new healthy cells, including cilia and mucus-producing goblet cells, to repopulate
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Lung Cancer
ALTITUDE STUDY
A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules
WHOSubjects with new, incidentally identified, solid lung nodule determined to be low-moderate risk of cancer
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WHATA Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules
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HOWThe Nodify XL2 test measures two proteins associated with an inflammatory response to lung cancer to help physicians identify nodules that are likely benign
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Tracheobronchomalacia
CPAP Study
Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)
WHOAdult patints with a diagnosis of ECAC either via bronchoscopy or CT Scan
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WHATProspective, Randomized placebo-control. We plan to enroll a total of 32 patients with ECAC randomized by an opaque envelope technique into two different groups: group 1 (CPAP) and group 2 (sham-CPAP)
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HOWUse of a CPAP during a 6-minute walk test to maintain the airways open during the respiratory cycle
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Lung Infections
LTI-01 Study
A Phase 2 randomized, placebo-controlled, double-blind, dose-ranging study evaluating LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions
WHOPatients with complicated parapneumonic pleural effusion (CPE), empyema or other type of pleural infection
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WHATA Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-ranging Study Evaluating LTI-01 (Single-chain Urokinase Plasminogen Activator, scuPA) in Patients With Infected, Non-draining Pleural Effusions
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HOWTreatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery
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