NCT07468617

Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: CSA Medical, Inc. · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS.

Detailed description

This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS. This is an open-label study. Eligible subjects will have previously completed the SPRAYCB study (NCT03893370). Subjects will receive 2 sessions of bronchial metered cryospray using RejuvenAir® System. Each session will be separated by approximately 30-45 days. Subjects will be followed at 3-month and at 6-months post second procedure.

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)
• Chronic Bronchitis

Interventions

Type	Name	Description
DEVICE	Metered cryospray (MCS)	Bronchial metered cryospray (MCS)

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-31
• Completion: 2027-05-01
• First posted: 2026-03-12
• Last updated: 2026-03-18

Regulatory

• FDA-regulated device study