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

CSA Medical, Inc.21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

CryoSpray Ablation SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Franklin Square Hospital Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

The primary safety endpoint for this study is patient safety

Time frame: Throughout study

The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients

Time frame: Throughout Study

Data from ClinicalTrials.gov

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