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This study has been withdrawn prior to enrollment.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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 28, 2014