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

Not Applicable

Terminated

Conditions: Lung Cancer
Mesothelioma

Interventions: Device: CryoSpray Ablation

Registration Number: NCT00748085

Lead Sponsor: CSA Medical, Inc.

Brief Summary: 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)

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryospray Ablation	CryoSpray Ablation	Cryospray Ablation 4, 5-second spray cycles

Primary Outcome Measures

Name	Time	Method
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.	1 year

Secondary Outcome Measures