Expired Study
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Baltimore, Maryland 21237


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

17-00008-00


NCT ID:

NCT00747773


Secondary ID:


Study Acronym:

CSAir 1


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

CSA Medical, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

Official Name:Willaim Krimsky, MD
Principal Investigator
PCCAB, Franklin Square Hospital Center

Study Dates

Start Date:November 2007
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 8, 2014
First Received Date:September 3, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary safety endpoint for this study is patient safety
Time Frame:Throughout study
Safety Issues:True
Outcome Type:Primary Outcome
Measure:The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients
Time Frame:Throughout Study
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:CryoSpray Ablation System
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 us

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:CSA Medical, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:19664781

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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