Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- CSA Medical, Inc.
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Improvement in Luminal Patency Following Cryospray Treatment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cryospray Ablation
Experimental CSA (Cryospray Ablation)
Intervention: CryoSpray Ablation (Device)
Outcomes
Primary Outcomes
Improvement in Luminal Patency Following Cryospray Treatment
Time Frame: 30 days
Secondary Outcomes
- Treatment Durability(12 months)