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Procedure

Dilatation vs. Laser Resection for Tracheal Stenosis (AERATE Trial)

N/A
Recruiting
Led By Marc Fortin
Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Less than 18 years old
Incapacity to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two methods to treat a narrowed windpipe: using a laser to cut away the blockage or using a balloon to stretch it open. It focuses on patients with non-cancerous narrowing of the windpipe. The goal is to see which method works better for these patients.

Who is the study for?
This trial is for adults over 18 with a simple, benign tracheal stenosis that's less than 1cm long and without cartilage damage. It's open to those getting their first treatment or having a recurrence but not to individuals with inflammation-related conditions, those unable to consent, or pregnant women.
What is being tested?
The study compares two treatments for narrow airways due to benign tracheal stenosis: stretching the airway (dilatation) versus removing the blockage with a laser (endoscopic laser resection). Participants will be randomly assigned one of these treatments in multiple centers.
What are the potential side effects?
Possible side effects may include discomfort at the site of treatment, bleeding, risk of infection, temporary breathing difficulties post-procedure, and potential need for additional procedures if narrowing recurs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Endoscopic laser resectionExperimental Treatment1 Intervention
Using CO2, diode or similar wavelenght laser the stenotic tracheal segment will be vaporized allowing a less than 20% residual stenosis. Dilatation will not be performed after laser resection for residual stenosis.
Group II: DilatationExperimental Treatment1 Intervention
Using a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Endoscopic Laser Resection involves using a laser to precisely remove stenotic (narrowed) tissue from the trachea, which helps to clear the airway and improve breathing. This method is beneficial because it allows for targeted removal of the obstructive tissue with minimal damage to surrounding areas. Dilatation, on the other hand, involves mechanically widening the trachea using a balloon or other device to stretch the narrowed section. This method is important as it provides immediate relief by increasing the airway diameter, allowing for better airflow. Both treatments are crucial for tracheal stenosis patients as they directly address the airway obstruction, improving breathing and overall quality of life.

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor
36 Previous Clinical Trials
9,627 Total Patients Enrolled
Marc FortinPrincipal InvestigatorFondation IUCPQ
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Dilatation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04719845 — N/A
Tracheal Stenosis Research Study Groups: Endoscopic laser resection, Dilatation
Tracheal Stenosis Clinical Trial 2023: Dilatation Highlights & Side Effects. Trial Name: NCT04719845 — N/A
Dilatation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04719845 — N/A
~7 spots leftby Mar 2025