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

Sponsored by:	CSA Medical, Inc.
Information provided by:	CSA Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00754468

Purpose

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.

Condition	Intervention	Phase
Barrett's Esophagus Esophageal Cancer	Device: CryoSpray Ablation(TM)	Phase IV

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:

The primary effectiveness endpoints are the treatment effect and depth of injury in healthy tissue using endoscopic cryospray therapy in esophagectomy subjects. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective of the study is to determine the side effects of subjects receiving cryospray therapy. [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator 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.	Device: 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: Active Comparator 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.	Device: 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.

Arms

Assigned Interventions

Group 1: Active Comparator

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.

Device: 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: Active Comparator

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.

Device: 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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years of age
Esophagectomy planned based on clinical situation not related to this study.
Deemed operable based on institutional criteria.

Exclusion Criteria:

Pregnant
Esophageal stricture preventing passage of endoscope or catheter.
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 or concurrent endoscopic ablation therapy within 4 cm from the CSA treatment area including, but not limited to, cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation, or argon plasma coagulation.
Prior radiation therapy which involved the esophagus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754468

Locations

United States, Florida
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136

Sponsors and Collaborators

CSA Medical, Inc.

Investigators

Principal Investigator:

Afonso Ribeiro, M.D.

Sylvester Cancer Center

More Information

Click here to learn more about CryoSpray Ablation(TM) This link exits the ClinicalTrials.gov site

Publications:

Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8.

Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92.

Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7.

Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54.

Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.

Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review.

Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34.

Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. Review.

Johnston MH, Horwhat JD, Haluska, Moses FM. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model (Abstract). Gastrointestinal Endoscopy 51: AB98, 3462, 2000.

Eastone JA, Horwhat D, Haluska O, Mathews J, Johnston M. Cryoablation of swine esophageal mucosa: A direct comparison to argon plasma coagulation (APC) and multipolar electrocoagulation (MPEC) [Abstract] Gastrointestinal Endoscopy 53: A3448, 2001.

Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.

Johnston MH, Cash BD, Horwhat JD, Johnston LR, Dykes CA, Mays HS. Cryoablation of Barrett's Esophagus (BE) [Abstract]. Gastroenterology 130 (4, Suppl.2): A640, 2006.

Johnston MH, Cash BD, Dykes CA, Mays HS, Johnston LR. Cryoablation of dysplasia in Barrett's Esophagus (BE) and early stage esophageal cancer [Abstract]. Gastrointestinal Endoscopy 63 (5): April, 2006.

Responsible Party:	CSA Medical, Inc. ( Karen McKenzie, Clinical Trials Project Manager )
Study ID Numbers:	16-00017
Study First Received:	September 16, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00754468
Health Authority:	United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:

Barrett's Esophagus
Esophageal Cancer
Esophageal Dysplasia
Low Grade Dysplasia
High Grade Dysplasia

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Digestive System Abnormalities
Esophageal disorder
Gastrointestinal Diseases
Head and Neck Neoplasms

Esophageal Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009