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

Primary Purpose

Radiation Proctitis, Radiation Induced Proctitis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cryo Spray Ablation Group 1
Cryo Spray Ablation Group 2
Sponsored by
CSA Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation Proctitis focused on measuring Radiation Proctitis, Radiation Induced Proctitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cryo Spray Ablation Group 1

    Cryo Spray Ablation Group 2

    Arm Description

    4 cycles of 10 seconds each

    2 cycles of 20 seconds each

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 18, 2008
    Last Updated
    August 6, 2015
    Sponsor
    CSA Medical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00756197
    Brief Title
    CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis
    Acronym
    CSALGI2
    Official Title
    A Single Center Pilot Study of CryoSpray Ablation(TM) to Determine Safety and Feasibility in Radiation Induced Proctitis (CSA LGI-2)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Considering more robust design.
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    March 2009 (Anticipated)
    Study Completion Date
    September 2009 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CSA Medical, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radiation Proctitis, Radiation Induced Proctitis
    Keywords
    Radiation Proctitis, Radiation Induced Proctitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cryo Spray Ablation Group 1
    Arm Type
    Experimental
    Arm Description
    4 cycles of 10 seconds each
    Arm Title
    Cryo Spray Ablation Group 2
    Arm Type
    Experimental
    Arm Description
    2 cycles of 20 seconds each
    Intervention Type
    Device
    Intervention Name(s)
    Cryo Spray Ablation Group 1
    Other Intervention Name(s)
    CryoSpray Ablation, Cryospray, Cryotherapy, Cryo Spray Ablation
    Intervention Description
    Cryo Spray Ablation
    Intervention Type
    Device
    Intervention Name(s)
    Cryo Spray Ablation Group 2
    Intervention Description
    cryo spray ablation
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary Lee Krinsky, D.O.
    Organizational Affiliation
    VA San Diego Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16301023
    Citation
    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. doi: 10.1016/j.gie.2005.05.008.
    Results Reference
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    PubMed Identifier
    10385730
    Citation
    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. doi: 10.1016/s0016-5107(99)70352-4.
    Results Reference
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    PubMed Identifier
    10734018
    Citation
    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. doi: 10.1016/s0016-5085(00)70136-3.
    Results Reference
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    PubMed Identifier
    8076761
    Citation
    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. doi: 10.1016/0016-5085(94)90123-6.
    Results Reference
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    PubMed Identifier
    8995932
    Citation
    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.
    Results Reference
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    PubMed Identifier
    14629105
    Citation
    Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.
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    PubMed Identifier
    17367523
    Citation
    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. doi: 10.1186/1477-7819-5-34.
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    PubMed Identifier
    10349923
    Citation
    Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.
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    Citation
    Dumot JA. Cryotherapy Ablation for Esophageal HGD or IMCA in High Risk, Non-Surgical Patients. DDW2007 Abstract submission. Cleveland Clinic Foundation (pending publication)
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    Citation
    Greenwald BD. CryoSpray Ablation of Early Esophageal Cancer. DDW 2007 Abstract submission. University of Maryland Medical Center. (pending publication)
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    Citation
    Johnston M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.
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    Citation
    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.
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    Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 2000.
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    Citation
    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.
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    Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.
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    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.
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    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.
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    CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis

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