Recruiting soon

Airway Exchange Broncholaryngoscope Feasibility and Safety Study during Tracheostomy Tube Exchanges

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Study Aim

This study examines if using the Airway Exchange Broncholaryngoscope (AEBLScope) during tracheostomy tube exchanges is feasible and safe.

What is being tested

Airway-Exchange Broncholaryngoscope (AEBLScope)

Device
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorUniversity of Southern California
Study ContactRoger Boles, M.D.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2025

Actual date on which the first participant was enrolled.

This study explores a new device called the AEBLScope, which is a specially designed, disposable tool helping doctors see more clearly when they change breathing tubes in patients. The goal is to test if this device is safe and easy to use during routine tracheostomy tube changes, which are procedures often done for patients who need help breathing through a tube in their neck. The study focuses on patients considered low-risk to ensure the device works well in a controlled setting before considering broader use. This research is important as it could lead to safer and more efficient tube changes, potentially reducing complications during the procedure. Participants in the study will undergo their regular tracheostomy tube exchange, but with the use of the AEBLScope to provide doctors with better visualization. This means the device will help the medical team see inside the airway more clearly while changing the tube. Throughout the study, researchers will monitor the process to ensure the device is safe and effective. The study does not list specific risks or benefits, but the potential benefit is that it could make tracheostomy tube changes safer and quicker in the future.

Official TitlePilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges 
NCT07033702
Principal SponsorUniversity of Southern California
Study ContactRoger Boles, M.D.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Device Feasibility Study

These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Age ≥18 years * Chronically (\>1 month) tracheostomy-dependent outpatients * Currently not requiring ventilatory or supplemental oxygen support * Have undergone at least one prior tracheostomy tube exchange * Scheduled for routine in-office tracheostomy tube exchange * Able to provide informed consent Exclusion Criteria: * Active respiratory infection * Patients with airway tubes having an inner diameter less than 6.0 mm * Patients with preexisting pulmonary conditions, including chronic obstructive pulmonary disease (COPD), restrictive lung disease, untreated pneumonia, or acute respiratory distress syndrome (ARDS) * Patients who are tracheostomy-dependent but cannot be orotracheally intubated. * Patients unable to provide informed consent and who have no legally authorized representative.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Keck Hospital of USC

Los Angeles, United StatesSee the location
Suspended

Los Angeles General Medical Center

Los Angeles, United States
Recruiting soon2 Study Centers