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

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by:
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00747916
First received: September 4, 2008
Last updated: May 27, 2009
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Primary Malignancy With Metastasis to the Parietal Pleura
Pleural Surface Neoplasms
 Device: CryoSpray Ablation (TM) System
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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")

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: August 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CryoSpray Ablation (TM) System
    Subjects will be treated with CryoSpray therapy 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:
    • CryoSpray Ablation (TM) System
    • CSA (TM) System
    • CryoSpray Therapy
    • CSA
    • Cryotherapy
    • Cryospray
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747916

Locations
United States, Texas
University of Texas Health Center at Tyler - Titus Regional Hospital
Tyler, Texas, United States, 75702
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Principal Investigator: Gordon Downie, M.D., Ph.D University of Texas Health Center at Tyler
  More Information

Additional Information:
Click here to learn more about CryoSpray Ablation (TM)  This link exits the ClinicalTrials.gov site

Publications:
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.

Responsible Party: Karen McKenzie, CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00747916     History of Changes
Other Study ID Numbers: 17-00027
Study First Received: September 4, 2008
Last Updated: May 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Parietal pleura
Neoplasms
Pleural Surface
Pleural Neoplasms
Lung Cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013