NCT07033702

Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tracheotomy Patients
• Airway Management
• Airway Disease

Interventions

Type	Name	Description
DEVICE	Airway-Exchange Broncholaryngoscope (AEBLScope)	Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study