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

NCT00747916 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-07-16

Study results available
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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.

Conditions

Interventions

DEVICE

CryoSpray Ablation (TM) System

Subjects will be treated with spray cryotherapy using the CryoSpray Ablation (TM) System at Day 0 using up to 3 cycles of 10-40 second sprays as the studied dosimetry and will cover the affected area, including the tumor and the parietal pleural surface. If disease exists bilaterally, only one side will be sprayed. Subjects will be assessed 2-5 days from the initial treatment (Day 0) to check for mucosal sloughing, to reassess tumor burden and for additional CSA therapy as needed.

Sponsors & Collaborators

  • CSA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Gordon Downie, M.D., Ph.D · University of Texas Health Center at Tyler

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00747916 on ClinicalTrials.gov