Clinical Trial: Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")

Brief 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)

Detailed Summary: 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.
Sponsor: CSA Medical, Inc.

Current Primary Outcome: Improvement in Luminal Patency Following Cryospray Treatment [ Time Frame: 30 days ]

Original Primary Outcome: 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. [ Time Frame: 24 months ]

Current Secondary Outcome: Treatment Durability [ Time Frame: 12 months ]

need for additional treatments within specified period


Original Secondary Outcome: A Measure of Treatment Durability. If After the Initial Repeat Bronchoscopy, the Investigator Determines That There is no Immediate Need for Further Intervention, Then Any Future Bronchoscopy Will be Performed Upon the Patient Presenting With Symptoms. [ Time Frame: 24 months ]

Information By: CSA Medical, Inc.

Dates:
Date Received: September 4, 2008
Date Started: October 2008
Date Completion:
Last Updated: August 11, 2015
Last Verified: August 2015