Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")
Stopped early · Phase 4
Conditions studied: Cancer, Pleural Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00747916
- Run by
- CSA Medical, Inc.
- People needed
- 3
- Starts
- 2008-08-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2015-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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 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
Where it is running
- University of Texas Health Center at Tyler - Titus Regional Hospital — Tyler, Texas, United States
Full record on ClinicalTrials.gov
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