Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung

Lung Cancer Clinical Trial

— CSAir 1  

Official title:

A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747773
• Other study ID #: 17-00008-00
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2008
• Last updated: January 8, 2014
• Start date: November 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2014
• Source: CSA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Franklin Square Hospital Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
CSA Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary safety endpoint for this study is patient safety		Throughout study
Primary	The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients		Throughout Study

External Links

•   Website of sponsor