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

PHASE4TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
CancerPleural Neoplasms
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.

Trial Locations (1)

75702

University of Texas Health Center at Tyler - Titus Regional Hospital, Tyler

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSA Medical, Inc.

INDUSTRY

NCT00747916 - "Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space(ICE PLS)" | Biotech Hunter | Biotech Hunter