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

NCT ID: NCT00747773

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-08-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSA Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willaim Krimsky, MD

Role: PRINCIPAL_INVESTIGATOR

PCCAB, Franklin Square Hospital Center

Locations

Franklin Square Hospital Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19664781 (View on PubMed)

Other Identifiers

17-00008-00

Identifier Type: -

Identifier Source: org_study_id