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

Phase 4

Terminated

• Conditions: Rhinoscleroma; Lung Diseases, Obstructive; Wegener's Granulomatosis; Recurrent Respiratory Papillomatosis; Sarcoidosis
• Interventions: Device: CryoSpray Ablation

• Registration Number: NCT00747461
• Lead Sponsor: CSA Medical, Inc.

Brief Summary

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)

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 Timeline

• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Study Start: 2008-10
• Primary Completion: 2010-03
• Study Completion: 2011-03
• Results First Submitted: 2015-06-04
• Results First Submitted QC: 2015-06-04
• Results First Posted: 2015-06-26
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryospray Ablation	CryoSpray Ablation	Experimental CSA (Cryospray Ablation)

Primary Outcome Measures

Name	Time	Method
Improvement in Luminal Patency Following Cryospray Treatment	30 days

Secondary Outcome Measures

Name	Time	Method
Treatment Durability	12 months	need for additional treatments within specified period

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States