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Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung (CSAir 1)

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ClinicalTrials.gov Identifier: NCT00747773
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.

Brief Summary:
The purpose of this study is to evaluate the feasibility and general safety in the human airway as well as assess the safety and depth and area of treatment using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) using surgical resection specimens from patients undergoing lobectomy.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: CryoSpray Ablation System Phase 4

Detailed Description:

The primary endpoints for this study are patient safety and the histological effects of cryospray therapy in lobectomy patients.

The proposed study is a single center study to evaluate the safety and treatment effect of sprayed liquid nitrogen through a catheter via FFB using surgical resection specimens from patients undergoing lobectomy.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: CryoSpray Ablation System
    CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications" (K070893). As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold


Primary Outcome Measures :
  1. The primary safety endpoint for this study is patient safety [ Time Frame: Throughout study ]
  2. The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients [ Time Frame: Throughout Study ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18 years of age
  • Lobectomy planned based on clinical situation not related to this study.
  • Deemed operable based on institutional criteria.

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.
  • Prior radiation therapy which involved the lungs
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00747773


Locations
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United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
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Principal Investigator: Willaim Krimsky, MD PCCAB, Franklin Square Hospital Center

Additional Information:
Publications of Results:
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Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00747773     History of Changes
Other Study ID Numbers: 17-00008-00
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by CSA Medical, Inc.:
Lung Cancer
CryoPsray Ablation
CSA therapy
CSA treatment
Lobectomy
lung resection

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases