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CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00748085
First received: September 4, 2008
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the safety, and tissue effect of the CryoSpray Ablation(TM) System (CryoSpray Ablation(TM), "CSA" or "cryospray therapy") at multiple centers to treat malignant airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)


Condition Intervention Phase
Lung Cancer
Mesothelioma
Malignant Airway Obstruction
Device: CryoSpray Ablation (TM) System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Study of CryoSpray Ablation(tm)in Malignant Airway Disease to Determine, Safety, and Tissue Effect in the Lung (ICE the MAD)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Device: CryoSpray Ablation (TM) System
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 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 with CSA therapy every seven days 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. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
Other Names:
  • CryoSpray Ablation(TM)System
  • CSA (TM) System
  • Cryo Spray Therapy
  • CSA
  • Cryotherapy
  • Cryo Spray Ablation

Detailed Description:

The primary endpoint is efficacy of the cryogen on the tumor evaluated by histopathological data and visual inspection along with visual confirmation of an absence of scarring and stricturing of the airway. The primary safety endpoint is the reporting of all adverse events. The primary symptom measures are the St. Georges Respiratory Questionnaire (SGRQ) and the Borg Dyspnea Index (BDI).

The secondary endpoint will consist of a measure of treatment efficacy and improvement in luminal patency assessed by visual inspection. 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 subject presenting with symptoms.

The proposed study will take place at up to three centers consisting of up to a total of 30 subjects with malignant airway obstruction. 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 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 with CSA therapy every seven days 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. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.

The study population consists of up to 30 subjects with malignant airway obstruction as a consequence of an endoluminal tumor that obstructs a portion of the respiratory tree below the vocal chords. These subjects will have been apprised of Standard of Care options, and will have rejected those options or have been deemed ineligible for them. Subjects must have a signed consent form and satisfy all study inclusion and exclusion criteria.

It is estimated that enrollment will take approximately 6 months. Each subject will receive CryoSpray treatments over the course of 1 year.

  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 or greater
  • Deemed a candidate for cryotherapy based on physician physical or medical history review
  • Deemed inoperable 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 induction chemotherapy.
  • Radiation therapy within the last 30 days 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: NCT00748085

Locations
United States, California
St. Vincent Medical Center
Los Angeles, California, United States, 90025
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Principal Investigator: William S Krimsky, M.D. Franklin Square Hospital Center
  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: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00748085     History of Changes
Other Study ID Numbers: 08-0106
Study First Received: September 4, 2008
Results First Received: June 16, 2014
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Malignant Airway Disease
Lung Cancer
Inoperable Lung Cancer
Mesothelioma
Endoluminal Tumor

Additional relevant MeSH terms:
Airway Obstruction
Lung Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiration Disorders
Respiratory Insufficiency
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014