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CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis (CSA LGI-2)

This study has been withdrawn prior to enrollment.
(Study not yet started. Decided not to do the study. Considering more robust design.)
Sponsor:
Information provided by:
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00756197
First received: September 18, 2008
Last updated: May 28, 2009
Last verified: May 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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: October 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CryoSpray Ablation(TM)
    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.
    Other Names:
    • CryoSpray Ablation
    • Cryospray
    • Cryotherapy
    • Cryo Spray Ablation
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
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Principal Investigator: Mary Lee Krinsky, D.O. VA San Diego Medical Center
  More Information

Additional Information:
Click here for more information on CryoSpray Ablation(TM)  This link exits the ClinicalTrials.gov site

Publications:
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.
Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 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: Karen McKenzie, Clinical Trials Project Manager, CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00756197     History of Changes
Other Study ID Numbers: 17-00016-00
Study First Received: September 18, 2008
Last Updated: May 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Radiation Proctitis
Radiation Induced Proctitis

Additional relevant MeSH terms:
Proctitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Rectal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 13, 2013