Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00747461
First received: September 4, 2008
Last updated: June 4, 2015
Last verified: June 2015
Results First Received: June 4, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Benign Airway Disease
Sarcoidosis
Wegener's Granulomatosis
Rhinoscleroma
Recurrent Respiratory Papillomatosis(RRP)
Intervention: Device: CryoSpray Ablation (tm)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Subjects in BAD No text entered.

Participant Flow:   Overall Study
    All Subjects in BAD  
STARTED     5  
COMPLETED     0  
NOT COMPLETED     5  
study terminated by sponsor                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Subjects in BAD No text entered.

Baseline Measures
    All Subjects in BAD  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     2  
Gender  
[units: participants]
 
Female     3  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
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1.  Primary:   The Effectiveness Endpoint is an Improvement in Luminal Patency Following Cryospray Treatment Along With Visual Confirmation of an Absence of Scarring and Stricturing of the Airway. Primary Safety Endpoint is the Reporting of All Adverse Events.   [ Time Frame: 24 months ]

2.  Secondary:   A Measure of Treatment Durability. If After the Initial Repeat Bronchoscopy, the Investigator Determines That There is no Immediate Need for Further Intervention, Then Any Future Bronchoscopy Will be Performed Upon the Patient Presenting With Symptoms.   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ann Murphy Legg, Director of Clinical Research
Organization: CSA Medical
phone: 781-538-4732
e-mail: alegg@csamedical.com


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: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00747461     History of Changes
Other Study ID Numbers: 15-00026
Study First Received: September 4, 2008
Results First Received: June 4, 2015
Last Updated: June 4, 2015
Health Authority: United States: Institutional Review Board