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TerminatedPhase 4NCT00747916
Official study title

Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCryoSpray Ablation (TM) System

The study team can explain what participation involves.

Who it may be forCancer · Pleural Neoplasms

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 16, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?CSA Medical, Inc.

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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