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

Stopped early · Phase 4

Conditions studied: Lung Diseases, Obstructive, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma, Recurrent Respiratory Papillomatosis

In brief

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)

Key facts

Study ID

NCT00747461

Run by

CSA Medical, Inc.

People needed

5

Starts

2008-10-01

Expected to finish

2011-03-01

Last updated by the study team

2015-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age
• Deemed a candidate for cryotherapy based on physician physical or medical history review
• Deemed operable based on institutional criteria.

You may not qualify if…

• Pregnant or nursing
• Planning to sire a child while enrolled in the study
• Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
• Refusal or inability to give consent.
• Concurrent chemotherapy.
• Prior radiation therapy which involved the any area between the vocal chords and the diaphragm
• Medical contraindication or potential problem that would preclude study participation
• Concurrent participation in other experimental studies Uncontrolled coagulopathy or bleeding diathesis
• Serious medical illness, including:
• Uncontrolled congestive heart failure
• Uncontrolled angina
• Myocardial infarction
• Cerebrovascular accident within 6 months prior to study entry

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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