Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
NCT00747461 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2015-08-18
Summary
The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)
Conditions
- Lung Diseases, Obstructive
- Sarcoidosis
- Wegener's Granulomatosis
- Rhinoscleroma
- Recurrent Respiratory Papillomatosis
Interventions
- DEVICE
-
CryoSpray Ablation
Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days
Sponsors & Collaborators
-
CSA Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Michael Machuzak, M.D. · The Cleveland Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2010-03-31
- Completion
- 2011-03-31
Countries
- United States
Study Locations
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