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Esophageal Neoplasms

Barrett Esophagus

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Gastrointestinal Diseases

Esophageal Diseases

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Esophageal Cancer

cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds

cryo spray ablation applied to healthy tissue 2 cycles x20 seconds

Cryo Spray Ablation 4 cycles x 10 seconds treatment

Cryo Spray Ablation

Cryo Spray Ablation 2 cycles x 20 seconds

Afonso Ribeiro, M.D.

The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

The proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be divided into 2 Groups in a sequential fashion based on the time of enrollment (Subject 1 in Group1, Subject 2 in Group 2, Subject 3 in Group1, Subject 4 in Group 2, etc). Potential study subjects will be referred from clinical practice. After entry into the study with written informed consent, subjects will be scheduled for the EGD with cryospray ablation treatment 7 days prior to the expected esophagectomy date.

All subjects will receive narcotic analgesics to control symptoms.

Endpoints related to pathology will be assessed by two independent reviewers, one from the Institution's Department of Pathology, and one from an independent Pathology lab chosen by the sponsor. The reviewers will evaluate the pathology slides to assess maximal extent of depth of injury, side effects, and pathological changes associated with CSA. All reviewers will be blinded to the treatment conditions of the specimens.

Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)

histopathological findings analyzed to determine max depth of injury (mm)

University of Miami

CSA Medical, Inc.

Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.

CryoSpray Ablation(TM): 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.

Group 1

Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.

CryoSpray Ablation(TM): 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.

Group 2

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Dr. Alfonso Ribeiro

cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds

Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment

Group 1: Cryo Spray Ablation

cryo spray ablation applied to healthy tissue 2 cycles x20 seconds

Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds

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