PulmAIR trial
Demonstrate a suitable benefit/risk profile to support a subsequent pivotal trial of the safety and effectiveness of the implantable artificial bronchus (IAB) to support its indications statement
WHO Adults (at least 22 years of age) with severe emphysema (GOLD 3 or 4) who suffer from symptoms despite optimized medical and pharmaceutical management. The IAB may be placed in patients with heterogeneous or homogeneous disease and with any collateral ventilation status.
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WHATOpen-label, single arm Phase 2 study. It offers the option of IAB implantation into severe emphysema patients who suffer from hyperinflation despite optimized medical or pharmaceutical management options.
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HOWThe IAB relieves hyperinflation and allows bidirectional ventilation of the affected lobes. The IAB is packaged with a delivery device which is used to insert the IAB into the desired location;
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BREATHE-3 Trial
Assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment.
WHOParticipants 40–84 years old, with severe COPD-related homogeneous or heterogeneous emphysema, and significant breathlessness despite standard therapy
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WHATProspective, randomized, two arm, parallel group, concurrently controlled, open-label, multi-center clinical trial following up to 250 participants to 3 years.
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HOWThe Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways while eliminating the risk of pneumothorax and procedural complexities that have limited broader adoption of current interventions.
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CONVERT-II Trial
A trial to evaluate the safety and effectiveness of AeriSeal® System to block collateral ventilation (CV) and convert a severe emphysema patient from CV+ to CV- status
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WHO
Eligible patients are adults aged 40–80 years with severe emphysema who have stopped smoking for more than 8 weeks and have at least one suitable target lobe with collateral ventilation confirmed by the Chartis® System.
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WHAT
A multicenter, prospective, single-arm study is being conducted at 14 clinical centers across Europe and Australia to evaluate AeriSeal System to occlude collateral channels to convert a CV+ lung lobe to having little to no CV-
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HOW
Using the AeriSeal® System to target and treat the fissural defects that cause collateral ventilation between lung lobes, which preclude some severe COPD/emphysema patients from benefiting from minimally invasive bronchoscopic lung volume reduction (BLVR) treatment with Zephyr® Valves.
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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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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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