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Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days

CryoSpray Ablation

Michael Machuzak, M.D.

The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)

The proposed study is a single center pilot study consisting of up to 10 subjects with benign airway disease. Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first three to seven days after the initial treatment, to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy per week with CSA therapy for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. If disease exists bilaterally, only one side will be sprayed initially.

Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")

need for additional treatments within specified period

CSA Medical, Inc.

All subjects enrolled will received CSA cryospray.

CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system.

All Subjects Receiving CSA Cryospray

subjects will receive up to 4 -5 second cycles of cryospray ablation

Cryo Spray Ablation

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Ann Murphy Legg, Director of Clinical Research

study terminated by Sponsor-data not analyzed

Improvement in Luminal Patency Following Cryospray Treatment

Treatment Durability

subjects receiving up to 4 -5 second spray cycles

Overall Study

Lung Neoplasms

Asthma

Pulmonary Emphysema

Emphysema

Mesothelioma

Mesothelioma, Malignant

Bronchitis

Bronchitis, Chronic

Respiratory Tract Neoplasms

Thoracic Neoplasms

Bronchial Diseases

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Pulmonary Disease, Chronic Obstructive

Chronic Disease

Chronic Graft Versus Host Disease

Malignant Mesothelioma

William Krimsky, M.D.

The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with the CryoSpray Ablation™ System post-510K approval.

The proposed registry is a prospective, multi-center study of patients that are currently undergoing CryoSpray Ablation™. A maximum of 50 investigational sites will participate in this study.

The study population consists of patients who are being treated with the CryoSpray Ablation™ System for thoracic diseases. Enrolled subjects must have a signed consent form for data collection.

CryoSpray Ablation(tm)Thoracic Patient Registry

Reset Medical, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")	NCT00747461	Lung Diseases, ... Sarcoidosis Wegener's Granu... Rhinoscleroma Recurrent Respi...	CryoSpray Ablat...	18 Years -	CSA Medical, Inc.
CryoSpray Ablation(tm)Thoracic Patient Registry	NCT00785239	Lung Cancer Emphysema Chronic Bronchi... COPD Asthma Sarcoidosis Mesothelioma		18 Years -	CSA Medical, Inc.
CryoSpray Ablation(tm)Thoracic Patient Registry	NCT00785239	Lung Cancer Emphysema Chronic Bronchi... COPD Asthma Sarcoidosis Mesothelioma		18 Years -	CSA Medical, Inc.
CryoSpray Ablation(tm)Thoracic Patient Registry	NCT00785239	Lung Cancer Emphysema Chronic Bronchi... COPD Asthma Sarcoidosis Mesothelioma		18 Years -	CSA Medical, Inc.

Spots Global Cancer Trial Database for benign airway disease