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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

AERATE Trial Summary

This trial looks at whether endoscopic laser resection or dilatation is more effective in treating benign tracheal stenosis.

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.Check my eligibility

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.See study design

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.

AERATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure

Secondary outcome measures

Clinical COPD questionnaire

Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year

Rate and type of complications and adverse effects depending on the procedure

+7 more

Other outcome measures

Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure in the idiopathic and non idiopathic subroup as well as in the first episode and recurrence subgroups

AERATE 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.

Do I qualify?Apply below to find out

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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

9,634 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any capacity remaining for participants in this experiment?

"Yes indeed, according to the clinicaltrials.gov portal this research is still seeking volunteers. The trial was set up on March 17th 2021 and its details were last amended May 2nd 2022; at present 108 individuals are sought from a single centre."

Answered by AI

To what extent has enrollment increased in this experiment?

"Affirmative, the clinical trial is currently recruiting. According to its page on clinicaltrials.gov, this study was initially posted on March 17th 2021 and last updated in May 2nd 2022. The recruitment process requires 108 patients from a single medical institution."

Answered by AI

Recent research and studies

BMJ OpenJournal

Dilation Versus Laser Resection in Subglottic Stenosis: Protocol for a Prospective International Multicentre Randomised Controlled Trial (AERATE Trial)

Soumagne, Thibaud, Nicolas Guibert, Ihab Atallah, Yves Lacasse, Hervé Dutau, and Marc Fortin. 2022. “Dilation Versus Laser Resection in Subglottic Stenosis: Protocol for a Prospective International Multicentre Randomised Controlled Trial (AERATE Trial)”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-053730.

clinicaltrials.govStudy

DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

Marc Fortin 2021. "DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04719845.