Status:
COMPLETED
Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Lead Sponsor:
CSA Medical, Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the feasibility and general safety in the human airway as well as assess the safety and depth and area of treatment using liquid nitrogen sprayed through a cat...
Detailed Description
The primary endpoints for this study are patient safety and the histological effects of cryospray therapy in lobectomy patients. The proposed study is a single center study to evaluate the safety and...
Eligibility Criteria
Inclusion
- Age 18 years of age
- Lobectomy planned based on clinical situation not related to this study.
- 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 lungs
- 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 :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00747773
Start Date
November 1 2007
End Date
August 1 2008
Last Update
January 9 2014
Active Locations (1)
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1
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237