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

September 4, 2008
August 11, 2015
October 2008
March 2010   (final data collection date for primary outcome measure)
Improvement in Luminal Patency Following Cryospray Treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00747461 on ClinicalTrials.gov Archive Site
Treatment Durability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
need for additional treatments within specified period
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")

The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)

The proposed study is a single center pilot study consisting of up to 10 subjects with benign airway disease. Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first three to seven days after the initial treatment, to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy per week with CSA therapy for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. If disease exists bilaterally, only one side will be sprayed initially.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Diseases, Obstructive
  • Sarcoidosis
  • Wegener's Granulomatosis
  • Rhinoscleroma
  • Recurrent Respiratory Papillomatosis
Device: CryoSpray Ablation
Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days
Other Names:
  • CryoSpray Ablation(TM)System
  • Cryotherapy
  • Cryosurgery
  • Cryospray
  • Cryo
Experimental: Cryospray Ablation
Experimental CSA (Cryospray Ablation)
Intervention: Device: CryoSpray Ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
March 2011
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age
  • Deemed a candidate for cryotherapy based on physician physical or medical history review
  • Deemed operable based on institutional criteria.

Exclusion Criteria:

  • Pregnant or nursing
  • 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.
  • Refusal or inability to give consent.
  • Concurrent chemotherapy.
  • Prior radiation therapy which involved the any area between the vocal chords and the diaphragm
  • Medical contraindication or potential problem that would preclude study participation
  • Concurrent participation in other experimental studies Uncontrolled coagulopathy or bleeding diathesis

Serious medical illness, including:

  • Uncontrolled congestive heart failure
  • Uncontrolled angina
  • Myocardial infarction
  • Cerebrovascular accident within 6 months prior to study entry
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00747461
15-00026
No
CSA Medical, Inc.
CSA Medical, Inc.
Not Provided
Principal Investigator: Michael Machuzak, M.D. The Cleveland Clinic
CSA Medical, Inc.
August 2015

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