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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This study has been withdrawn prior to enrollment.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

September 18, 2008
May 28, 2009
October 2008
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00756197 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis
A Single Center Pilot Study of CryoSpray Ablation(TM) to Determine Safety and Feasibility in Radiation Induced Proctitis (CSA LGI-2)

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Radiation Proctitis
  • Radiation Induced Proctitis
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
10
September 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00756197
17-00016-00
No
Karen McKenzie, Clinical Trials Project Manager, CSA Medical, Inc.
CSA Medical, Inc.
Not Provided
Principal Investigator: Mary Lee Krinsky, D.O. VA San Diego Medical Center
CSA Medical, Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP