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Sponsored by: |
CSA Medical, Inc. |
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Information provided by: | CSA Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00747461 |
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)
Condition | Intervention | Phase |
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Benign Airway Disease Sarcoidosis Wegener's Granulomatosis Rhinoscleroma Recurrent Respiratory Papillomatosis(RRP) |
Device: CryoSpray Ablation (tm) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD") |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Serious medical illness, including:
Responsible Party: | CSA Medical, Inc. ( Karen McKenzie, Clinical Trials Project Manager ) |
Study ID Numbers: | 15-00026 |
Study First Received: | September 4, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00747461 |
Health Authority: | United States: Institutional Review Board |
Benign Airway Disease Airway Injury Sarcoidosis |
Wegener's Granulomatosis Rhinoscleroma Recurrent Respiratory Papillomatosis(RRP) |
Bacterial Infections Wegener's granulomatosis Gram-Negative Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Urologic Diseases Skin Diseases, Bacterial Kidney Diseases Neoplasms, Squamous Cell Papilloma Lung Diseases, Interstitial Otorhinolaryngologic Diseases Vasculitis Skin Diseases |
Enterobacteriaceae Infections Vascular Diseases Sarcoidosis Recurrence Klebsiella Lymphatic Diseases Skin Diseases, Infectious Wegener Granulomatosis Lung Diseases Rhinoscleroma Klebsiella Infections Lymphoproliferative Disorders Recurrent respiratory papillomatosis Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Cardiovascular Diseases Infection Nose Diseases |