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

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: August 11, 2015
Last verified: August 2015
Results First Received: June 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Diseases, Obstructive
Sarcoidosis
Wegener's Granulomatosis
Rhinoscleroma
Recurrent Respiratory Papillomatosis
Intervention: Device: CryoSpray Ablation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cryo Spray Ablation subjects receiving up to 4 -5 second spray cycles

Participant Flow:   Overall Study
    Cryo Spray Ablation  
STARTED     5  
COMPLETED     0  
NOT COMPLETED     5  
study terminated by sponsor                 5  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Cryo Spray Ablation subjects will receive up to 4 -5 second cycles of cryospray ablation

Baseline Measures
    Cryo Spray Ablation  
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
  Show All Outcome Measures

1.  Primary:   Improvement in Luminal Patency Following Cryospray Treatment   [ Time Frame: 30 days ]

2.  Secondary:   Treatment Durability   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.
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: August 11, 2015
Health Authority: United States: Institutional Review Board