A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
IAB-2 is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from severe COPD/emphysema. There is no control group or comparator. The study will be conducted at as many as twelve sites in the United States and three sites outside of the US, in the Netherlands, Germany and Brazil.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Implantable Artificial Bronchus (IAB) is a tapered, flexible and fenestrated polymer-based airway stent that is implanted bronchoscopically using a proprietary delivery system into diseased lungs of patients with emphysema.
Absolute change in residual volume (RV)
The primary endpoint is the absolute change in residual volume (RV) from baseline to endpoint as recorded 90-days after the last implant.
Time frame: 90 days after last IAB is implanted
Changes from baseline to 90-days, involving pulmonary function, exercise tolerance, dyspnea burden and occurrence as well as all related adverse device effects
Absolute change in Forced Expiratory Volume in one second (FEV1) from baseline to endpoint; Absolute change in residual volume/total lung capacity (RV/TLC) from baseline to endpoint; Absolute change in Six-minute Walk Distance (6MWD); Absolute change in the St George's Respiratory Questionnaire (SGRQ) total score where a higher score represents more significant impact of the disease on wellbeing; Absolute change in the Modified Medical Research Counsel Questionnaire (mMRC) dyspnea score; Absolute changes in COPD Assessment Test (CAT), with higher scores indicating a greater impact of COPD on health; Absolute change in EQ-5D Summary Index Questionnaire which measures self-reported assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression with a higher score indicating more significant impact of the disease on each dimension. Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs) and Device Deficiencies (DDs) with SADE potential
Time frame: 90 days after last implant
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