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CSALGI2: CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis

Sponsor
CSA Medical, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00756197
Collaborator
(none)
0
Enrollment
2
Arms
11
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Cryo Spray Ablation Group 1
  • Device: Cryo Spray Ablation Group 2
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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)
Study Start Date :
Oct 1, 2008
Anticipated Primary Completion Date :
Mar 1, 2009
Anticipated Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cryo Spray Ablation Group 1

4 cycles of 10 seconds each

Device: Cryo Spray Ablation Group 1
Cryo Spray Ablation
Other Names:
  • CryoSpray Ablation
  • Cryospray
  • Cryotherapy
  • Cryo Spray Ablation

    		•
    Experimental: Cryo Spray Ablation Group 2

    2 cycles of 20 seconds each

    Device: Cryo Spray Ablation Group 2
    cryo spray ablation

    Outcome Measures

    Primary Outcome Measures

    1. The primary endpoints for this study are patient safety, treatment efficacy, and feasibility of cryospray therapy in subjects with radiation proctitis. [End of Study]

    Secondary Outcome Measures

    1. The secondary endpoints for the study are the cataloging of side effects, and tissue response as determined by endoscopic visual evaluation. [End of Study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CSA Medical, Inc.

    Investigators

    • Principal Investigator: Mary Lee Krinsky, D.O., VA San Diego Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    CSA Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT00756197
    Other Study ID Numbers:
    • 17-00016-00
    First Posted:
    Sep 22, 2008
    Last Update Posted:
    Aug 7, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by CSA Medical, Inc.
    Radiation Proctitis
    Radiation Induced Proctitis
    Additional relevant MeSH terms:
    Proctitis

    Study Results

    No Results Posted as of Aug 7, 2015