Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")
The proposed study is a single center pilot study consisting of up to 10 subjects with
benign airway disease. Treatment dosimetry will be up to 4, 5-second spray cycles.
Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat
bronchoscopy in the first three to seven days after the initial treatment, to check for
mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to
one bronchoscopy per week with CSA therapy for a total of four (4) treatments in the first
month. If they present with symptoms thereafter, then a repeat bronchoscopy will be
performed; if luminal obstruction is noted, then the subject will begin the treatment
protocol again. If disease exists bilaterally, only one side will be sprayed initially.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The effectiveness endpoint is an improvement in luminal patency following cryospray treatment along with visual confirmation of an absence of scarring and stricturing of the airway. Primary safety endpoint is the reporting of all adverse events.
Michael Machuzak, M.D.
The Cleveland Clinic
United States: Institutional Review Board
|Cleveland Clinic Foundation||Cleveland, Ohio 44195|