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

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Brief Title

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

Official Title

Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")

Brief Summary

      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)
    

Detailed Description

      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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Improvement in Luminal Patency Following Cryospray Treatment

Secondary Outcome

 Treatment Durability

Condition

Lung Diseases, Obstructive

Intervention

CryoSpray Ablation

Study Arms / Comparison Groups

 Cryospray Ablation
Description:  Experimental CSA (Cryospray Ablation)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

5

Start Date

October 2008

Completion Date

March 2011

Primary Completion Date

March 2010

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Machuzak, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00747461

Organization ID

15-00026


Responsible Party

Sponsor

Study Sponsor

CSA Medical, Inc.


Study Sponsor

Michael Machuzak, M.D., Principal Investigator, The Cleveland Clinic


Verification Date

August 2015