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

August 11, 2015 updated by: CSA Medical, Inc.

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryospray Ablation
Experimental CSA (Cryospray Ablation)
Device: CryoSpray Ablation
Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days
Other Names:
  • Cryotherapy
  • Cryosurgery
  • Cryo
  • Cryospray
  • CryoSpray Ablation(TM)System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Luminal Patency Following Cryospray Treatment
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Durability
Time Frame: 12 months
need for additional treatments within specified period
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSA Medical, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (Estimate)

September 5, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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