Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")
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.
Checked against the public recordLast updated Jul 16, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- CSA Medical, Inc.
- Interventions being studied
- Device: CryoSpray Ablation (TM) System
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Texas Health Center at Tyler - Titus Regional HospitalTyler, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 16, 2015. Always confirm current availability with the study team.