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

Phase 4TerminatedNCT00747461

CSA Medical, Inc.5 enrolled

Overview

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)

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Diseases, Obstructive Sarcoidosis Wegener's Granulomatosis Rhinoscleroma Recurrent Respiratory Papillomatosis

Interventions

CryoSpray AblationDEVICE

Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Improvement in Luminal Patency Following Cryospray Treatment

Time frame: 30 days

Secondary Outcomes

Treatment Durability

need for additional treatments within specified period

Time frame: 12 months

Data from ClinicalTrials.gov

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