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

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by:
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00747461
First received: September 4, 2008
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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)


Condition Intervention Phase
Benign Airway Disease
Sarcoidosis
Wegener's Granulomatosis
Rhinoscleroma
Recurrent Respiratory Papillomatosis(RRP)
Device: CryoSpray Ablation (tm)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")

Resource links provided by NLM:


Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CryoSpray Ablation (tm)
    The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system.
    Other Names:
    • CryoSpray Ablation(TM)System
    • Cryotherapy
    • Cryosurgery
    • Cryospray
    • Cryo
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747461

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Principal Investigator: Michael Machuzak, M.D. The Cleveland Clinic
  More Information

Additional Information:
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: Karen McKenzie, Clinical Trials Project Manager, CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00747461     History of Changes
Other Study ID Numbers: 15-00026
Study First Received: September 4, 2008
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Benign Airway Disease
Airway Injury
Sarcoidosis
Wegener's Granulomatosis
Rhinoscleroma
Recurrent Respiratory Papillomatosis(RRP)

Additional relevant MeSH terms:
Sarcoidosis
Wegener Granulomatosis
Respiratory Tract Infections
Papillomavirus Infections
Rhinoscleroma
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Infection
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Klebsiella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Nose Diseases
Otorhinolaryngologic Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014