Status:
TERMINATED
Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")
Lead Sponsor:
CSA Medical, Inc.
Conditions:
Cancer
Pleural Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and side effects of the CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal pleural surface.
Detailed Description
The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci. I...
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
- Able to sign informed consent
- Documented lung or other visceral cancer with pleural involvement.
- WBC \> 4,000/mm3, platelets \>100,000mm3
- Physically well enough to undergo moderate sedation and pleuroscopy
- Female patients must be HCG negative
- There should be direct evidence of disease progression despite treatment in previously treated patients
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.
- 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 :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00747916
Start Date
August 1 2008
End Date
August 1 2009
Last Update
July 16 2015
Active Locations (1)
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1
University of Texas Health Center at Tyler - Titus Regional Hospital
Tyler, Texas, United States, 75702