Status:
TERMINATED
CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)
Lead Sponsor:
CSA Medical, Inc.
Conditions:
Lung Cancer
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 malignan...
Detailed Description
The primary endpoint is efficacy of the cryogen on the tumor evaluated by histopathological data and visual inspection along with visual confirmation of an absence of scarring and stricturing of the a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00748085
Start Date
October 1 2008
End Date
August 1 2009
Last Update
July 23 2015
Active Locations (1)
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1
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237