CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)

Stopped early · Not applicable

Conditions studied: Lung Cancer, Mesothelioma

In brief

The purpose of this study is to evaluate the safety, and tissue effect of the CryoSpray Ablation(TM) System (CryoSpray Ablation(TM), "CSA" or "cryospray therapy") at multiple centers to treat malignant airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)

Key facts

Study ID

NCT00748085

Run by

CSA Medical, Inc.

People needed

5

Starts

2008-10-01

Expected to finish

2009-08-01

Last updated by the study team

2015-07-23

Who can join

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

You may qualify if…

• 18 years of age or greater
• Deemed a candidate for cryotherapy based on physician physical or medical history review
• Deemed inoperable 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 induction chemotherapy.
• Radiation therapy within the last 30 days 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

• Franklin Square Hospital Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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