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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

Mesothelioma

Mesothelioma, Malignant

Respiratory Tract Neoplasms

Thoracic Neoplasms

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Malignant Mesothelioma

Cryospray Ablation 4, 5-second spray cycles

Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment. Subjects may undergo up to one bronchoscopy with CryoSpray Ablation every seven days for a total of four (4) treatments in the first month.

William S Krimsky, M.D.

The purpose of this study is to evaluate the safety, and tissue effect of the CryoSpray Ablation(TM) System (CryoSpray Ablation(TM), "CSA" or "cryospray therapy") at multiple centers to treat malignant airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)

The primary endpoint is efficacy of the cryogen on the tumor evaluated by histopathological data and visual inspection along with visual confirmation of an absence of scarring and stricturing of the airway. The primary safety endpoint is the reporting of all adverse events. The primary symptom measures are the St. Georges Respiratory Questionnaire (SGRQ) and the Borg Dyspnea Index (BDI).

The secondary endpoint will consist of a measure of treatment efficacy and improvement in luminal patency assessed by visual inspection. If after the initial repeat bronchoscopy, the investigator determines that there is no immediate need for further intervention, then any future bronchoscopy will be performed upon the subject presenting with symptoms.

The proposed study will take place at up to three centers consisting of up to a total of 30 subjects with malignant airway obstruction. 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 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 with CSA therapy every seven days 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. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.

The study population consists of up to 30 subjects with malignant airway obstruction as a consequence of an endoluminal tumor that obstructs a portion of the respiratory tree below the vocal chords. These subjects will have been apprised of Standard of Care options, and will have rejected those options or have been deemed ineligible for them. Subjects must have a signed consent form and satisfy all study inclusion and exclusion criteria.

It is estimated that enrollment will take approximately 6 months. Each subject will receive CryoSpray treatments over the course of 1 year.

CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)

A Multi-Center Study of CryoSpray Ablation(tm)in Malignant Airway Disease to Determine, Safety, and Tissue Effect in the Lung (ICE the MAD)

CryoSpray Ablation (TM) System: 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 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 with CSA therapy every seven days 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. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.

1-all Subjects

Ethnicity (NIH/OMB)

Race (NIH/OMB)

no analysis conducted-study terminated for business reasons

Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events.

no analysis conducted. Study terminated for business reasons

Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.

Digestive System Diseases

Mouth and Tooth Diseases

Esophageal Neoplasms

Deglutition Disorders

Barrett Esophagus

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Precancerous Conditions

Pharyngeal Diseases

Esophageal Cancer

CSA System (CryoSpray AblationTM System)

Bruce D Greenwald, M.D.

The purpose of this study is to confirm the effectiveness and safety of a new medical device which sprays liquid nitrogen through an upper endoscope (cryotherapy) to treat Barrett's esophagus with high-grade dysplasia and early esophageal cancer. It is hypothesized that this treatment will remove the abnormal lining of the esophagus and allow the normal esophageal lining to return.

Barrett's esophagus (BE) with high grade dysplasia (HGD) is a precursor of esophageal adenocarcinoma. Eliminating this condition may control the current rapid rise of adenocarcinoma. Ablative techniques are attempted to avoid the high morbidity and mortality of esophagectomy or for use in patients who cannot undergo surgery. Current ablative techniques have achieved mucosal ablation with variable success but are associated with high cost, patient discomfort and/or significant complications. A novel device which sprays liquid nitrogen through an upper endoscope (cryotherapy) has been shown to be a safe and effective procedure to ablate the esophageal mucosa in swine and dog models and in pilot studies in humans. Successful reversal of BE, LGD, HGD and superficial adenocarcinoma and squamous cell carcinoma have been demonstrated when cryotherapy with this device is followed by healing of the esophageal lining in a low acid environment.

This study is undertaken to demonstrate the efficacy and safety in the ablation of Barrett's esophagus with high-grade, neoplasia, and severe esophageal squamous dysplasia and to confirm preliminary results in humans.

Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer

Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer

HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma

HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma

Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma

Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence

Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia

Number of treatment sessions needed to ablate dysplasia

University of Maryland, Baltimore

Asthma

Pulmonary Emphysema

Emphysema

Bronchitis

Bronchitis, Chronic

Bronchial Diseases

Pulmonary Disease, Chronic Obstructive

Chronic Disease

Chronic Graft Versus Host Disease

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.

Ann Murphy Legg, RN

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

The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.

CryoSpray Ablation (TM) GI Patient Registry

Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact. Frozen state is defined as mucosa appearing white. Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray. This cycle is repeated 4 times in each area of treatment.

Cryospray Ablation

John A. Dumot, D.O.

This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold.

Patients will prepare for esophagogastroduodenoscopy (EGD) in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure. The EGD will be performed using a therapeutic Olympus endoscope. The cryocatheter is passed into the therapeutic channel of the endoscope. Liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer. This process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds. Following circumferential treatment, the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds. Patients will be contacted the following day to assess for any immediate complications.

Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury, until complete ablation of the Barrett's mucosa has been achieved. Follow up period of five years to monitor healing and progression.

Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers

A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers

Determined by the end of protocol biopsies: incremental (absence of HGD and IMCA in all specimens); partial (residual IMCA with absence of any dysplasia); complete (absence of any intestinal metaplasia or dysplasia)

Toxicity is defined as death or esophageal perforation

Number of patient with each response determined by the end of protocol biopsies: incremental (absence of HGD and IMCA in all specimens); partial (residual IMCA with absence of any dysplasia); complete (absence of any intestinal metaplasia or dysplasia); no response

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)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)	NCT00748085	Lung Cancer Mesothelioma	CryoSpray Ablat...	18 Years -	CSA Medical, Inc.
Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer	NCT00321958	Barrett Esophag... Esophageal Neop... Deglutition Dis... GERD Neoplasm	CSA System (Cry... CryoSpray Ablat...	18 Years -	University of Maryland, Baltimore
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) GI Patient Registry	NCT00747448	Barrett's Esoph... Esophageal Canc...		18 Years -	CSA Medical, Inc.
CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)	NCT00748085	Lung Cancer Mesothelioma	CryoSpray Ablat...	18 Years -	CSA Medical, Inc.
Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers	NCT00650988	Barretts Esopha... Esophageal Canc...	Cryospray Ablat...	18 Years -	Case Comprehensive Cancer Center
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 cryospray ablation