Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05895305
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2023-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis
Sponsor:
Airiver Medical, Inc.
Organization:
Study Overview
Official Title:
Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the treatment of benign central airway stenosis.
Detailed Description:
Benign central airway stenosis/obstruction, including stenosis of the subglottic area, trachea, and bronchi, is related to significant morbidity due to dyspnea and impaired quality of life. It is hypothesized that Airiver pulmonary drug-coated balloon (DCB) will improve patient outcome in the bronchoscopic treatment of benign airway obstruction, and, as an adjunct to standard of care, will prolong airway patency compared to the standard of care alone. This is a prospective, multi-center, single-arm, open-label, safety \& feasibility, OUS first in human study for safety and potential efficacy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: