CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis - Full Text View

Sponsored by:	CSA Medical, Inc.
Information provided by:	CSA Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00756197

Purpose

The purpose of this study is to evaluate the safety, feasibility, tissue response, and subject side effects of liquid nitrogen sprayed through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") via endoscope in subjects with radiation induced proctitis.

Condition	Intervention	Phase
Radiation Proctitis Radiation Induced Proctitis	Device: CryoSpray Ablation(TM)	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Center Pilot Study of CryoSpray Ablation(TM) to Determine Safety and Feasibility in Radiation Induced Proctitis (CSA LGI-2)

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

Primary Outcome Measures:

The primary endpoints for this study are patient safety, treatment efficacy, and feasibility of cryospray therapy in subjects with radiation proctitis. [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary endpoints for the study are the cataloging of side effects, and tissue response as determined by endoscopic visual evaluation. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

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

Intervention Details:

CSA Medical, Inc. received FDA market clearance for the CSA System (CryoSpray AblationTM 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, ten patient pilot study to evaluate the safety and feasibility of sprayed liquid nitrogen through a catheter via endoscope in subjects with radiation proctitis. There will be two groups. Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy. Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.

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
Have radiation induced proctitis

Exclusion Criteria:

Pregnant or nursing
Planning to become pregnant during the course of the study
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.

Subject has prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc

Refusal or inability to give consent.
Concurrent chemotherapy.
Medical contraindication or potential problem that would preclude study participation
Concurrent participation in other experimental studies
Uncontrolled coagulopathy or bleeding diathesis
Portal hypertension due to cirrhosis manifest by esophageal, gastric or rectal varices

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756197

Locations

United States, California
VA San Diego Medical Center
San Diego, California, United States, 92161
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

CSA Medical, Inc.

Investigators

Principal Investigator:	LTC John D Horwat, M.D.	Walter Reed Army Medical Center
Principal Investigator:	Mary Lee Krinsky, D.O.	VA San Diego Medical Center

More Information

Click here for more information on 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:	17-00016-00
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00756197
Health Authority:	United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:

Radiation Proctitis
Radiation Induced Proctitis

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Proctitis

Intestinal Diseases
Gastroenteritis
Rectal Diseases

ClinicalTrials.gov processed this record on January 16, 2009