Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed. This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Johns Hopkins University
Baltimore, Maryland, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Raleigh, North Carolina, United States
Treatment safety
Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
Time frame: 12 weeks
Technical success
Device deployment and infusion success
Time frame: procedure day
Airway patency improvements
Time frame: 6 weeks
Quality of Life
Time frame: 12 weeks
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