COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747916
Recruitment Status : Terminated (Business Reasons)
First Posted : September 8, 2008
Results First Posted : June 8, 2015
Last Update Posted : July 16, 2015
Information provided by (Responsible Party):
CSA Medical, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Pleural Neoplasms Device: CryoSpray Ablation (TM) System Phase 4

Detailed Description:

The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci.

Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary, dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if dosimetry will need to be increased to enhance effectiveness. The PI may increase dosimetry by 1 cycle after each subject is treated and observed as a conservative approach to efficacy determination. If disease exists bilaterally, only one side will be sprayed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Safety, Efficacy, and Side Effects of Interventional Cryotherapy for the Eradication of Disease in the Pleural Space ("ICE PLS")
Study Start Date : August 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: CryoSpray Ablation (TM) System
subjects will receive cryotherapy using the CryoSpray Ablation (TM) System DOSE: up to 3 cycles of 10-40 second sprays
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.
Other Names:
  • CSA (TM) System
  • CryoSpray Therapy
  • CSA
  • Cryotherapy
  • Cryospray

Primary Outcome Measures :
  1. To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747916

Layout table for location information
United States, Texas
University of Texas Health Center at Tyler - Titus Regional Hospital
Tyler, Texas, United States, 75702
Sponsors and Collaborators
CSA Medical, Inc.
Layout table for investigator information
Principal Investigator: Gordon Downie, M.D., Ph.D University of Texas Health Center at Tyler
Dumot JA. Cryotherapy Ablation for Esophageal HGD or IMCA in High Risk, Non-Surgical Patients. DDW2007 Abstract submission. Cleveland Clinic Foundation (pending publication)
Greenwald BD. CryoSpray Ablation of Early Esophageal Cancer. DDW 2007 Abstract submission. University of Maryland Medical Center. (pending publication)
Johnston M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.
Johnston MH, Horwhat JD, Haluska, Moses FM. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model (Abstract). Gastrointestinal Endoscopy 51: AB98, 3462, 2000.
Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 2000.
Eastone JA, Horwhat D, Haluska O, Mathews J, Johnston M. Cryoablation of swine esophageal mucosa: A direct comparison to argon plasma coagulation (APC) and multipolar electrocoagulation (MPEC) [Abstract] Gastrointestinal Endoscopy 53: A3448, 2001.
Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.
Johnston MH, Cash BD, Horwhat JD, Johnston LR, Dykes CA, Mays HS. Cryoablation of Barrett's Esophagus (BE) [Abstract]. Gastroenterology 130 (4, Suppl.2): A640, 2006.
Johnston MH, Cash BD, Dykes CA, Mays HS, Johnston LR. Cryoablation of dysplasia in Barrett's Esophagus (BE) and early stage esophageal cancer [Abstract]. Gastrointestinal Endoscopy 63 (5): April, 2006.

Layout table for additonal information
Responsible Party: CSA Medical, Inc. Identifier: NCT00747916    
Other Study ID Numbers: 17-00027
First Posted: September 8, 2008    Key Record Dates
Results First Posted: June 8, 2015
Last Update Posted: July 16, 2015
Last Verified: June 2015
Keywords provided by CSA Medical, Inc.:
Parietal pleura
Pleural Surface
Pleural Neoplasms
Lung Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Diseases
Respiratory Tract Diseases