Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-01-11 @ 4:50 AM
Study NCT ID:
NCT07033702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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:
This pilot study evaluates the safety and feasibility of a novel airway exchange broncholaryngoscope (AEBLScope) during routine tracheostomy tube exchanges in chronically tracheostomy-dependent adult outpatients.
Detailed Description:
The AEBLScope is a modified disposable bronchoscope designed to allow for simultaneous visualization during airway tube exchanges. This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: