Status:
TERMINATED
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
Lead Sponsor:
CSA Medical, Inc.
Conditions:
Lung Diseases, Obstructive
Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 dise...
Detailed Description
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 cry...
Eligibility Criteria
Inclusion
- 18 years of age
- Deemed a candidate for cryotherapy based on physician physical or medical history review
- Deemed operable 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 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00747461
Start Date
October 1 2008
End Date
March 1 2011
Last Update
August 18 2015
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195