NL-OMON40702
Completed
Phase 2
A Prospective Study of RejuvenAir* System Radial Spray Cryotherapy to Determine Safety and Histological Effect in the Lung - RejuvenAir* System Lobectomy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CSA Medical Inc.
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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