The objective of this study is to evaluate its safety and feasibility of the Airway Bypass Stent System in patients with severe emphysema. The study will collect clinical data through 12 months to assess procedural and device safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Bypass stent(s) are implanted to allow air trapped in the parenchyma to escape
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
RECRUITINGAdverse Events
including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.
Time frame: 12 Months
Implant Success
Device success, defined as the successful creation of the fenestration(s) and successful delivery of the stent(s) at the intended target position(s).
Time frame: 0 Days
Procedural success
Procedural success, defined as no occurrence of device-related or procedure-related SAEs during the hospital stay.
Time frame: 1 Days
CAT
Improvement of the COPD Assessment Test (CAT) score from baseline.
Time frame: 12 Months
FEV1
Improvement in forced expiratory volume in 1 second (FEV1) from baseline
Time frame: 12 Months
Residual Volume
Decrease in the Residual Volume (RV) from baseline
Time frame: 12 Months
6MWT
Improvement in the 6-minute walk test from baseline
Time frame: 12 Months
Dyspnea scale
Improvement in the mMRC dyspnea scale from baseline
Time frame: 12 Months
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