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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CryoSpray Ablation System
Sponsored by
CSA Medical, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, CryoPsray Ablation, CSA therapy, CSA treatment, Lobectomy, lung resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Franklin Square Hospital Center

Outcomes

Primary Outcome Measures

The primary safety endpoint for this study is patient safety
The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients

Secondary Outcome Measures

Full Information

First Posted
September 3, 2008
Last Updated
January 8, 2014
Sponsor
CSA Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00747773
Brief Title
Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Acronym
CSAir 1
Official Title
A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSA Medical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, CryoPsray Ablation, CSA therapy, CSA treatment, Lobectomy, lung resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CryoSpray Ablation System
Intervention Description
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 Measure Information:
Title
The primary safety endpoint for this study is patient safety
Time Frame
Throughout study
Title
The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients
Time Frame
Throughout Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willaim Krimsky, MD
Organizational Affiliation
PCCAB, Franklin Square Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19664781
Citation
Krimsky WS, Broussard JN, Sarkar SA, Harley DP. Bronchoscopic spray cryotherapy: assessment of safety and depth of airway injury. J Thorac Cardiovasc Surg. 2010 Mar;139(3):781-2. doi: 10.1016/j.jtcvs.2009.03.051. Epub 2009 Aug 6. No abstract available.
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Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung

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