A Prospective Study of RejuvenAir* System Radial Spray Cryotherapy to Determine Safety and Histological Effect in the Lung
Phase 2
Completed
- Conditions
- 10038716COPD
- Registration Number
- NL-OMON40702
- Lead Sponsor
- CSA Medical Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Subject is scheduled within 60 days, for a total lobectomy or pneumonectomy procedure unrelated to this study (upper and lower lobes only).
Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 50% of predicted.
Exclusion Criteria
Subject is pregnant, nursing, or planning to get pregnant during study duration.
Subject has had prior radiation therapy which involved the lungs.
Subject has received chemotherapy within the past 6 months, or is anticipated to be treated with chemotherapy between initial study treatment and lobectomy/pneumonectomy procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety as measured by occurrence of serious adverse events related to metered<br /><br>dose radial spray cryotherapy treatment performed prior to scheduled lobectomy<br /><br>or pneumonectomy surgery</p><br>
- Secondary Outcome Measures
Name Time Method <p>Description of tissue depth effect per specified dose using routine tissue<br /><br>staining.</p><br>