Wedge Resection vs Radial Incision for Tracheal Stenosis

CZ
Overseen ByChenchen Zhang, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Maryland, Baltimore
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Some people develop a narrowing of their windpipe (trachea), called benign tracheal stenosis, which can make it hard to breathe. Doctors often treat this by using a bronchoscope-a thin, flexible tube with a camera-to open up the airway or remove scar tissue. While these procedures help patients breathe better, we do not fully understand why the narrowing occurs or how the tissue heals afterward.

The purpose of this study is to better understand the biological changes in the airway tissue before and after these standard medical procedures. During the procedure, small samples of tissue that would already be collected as part of normal care will be analyzed in the laboratory. The results may help doctors learn more about airway healing and could guide better treatments in the future.

Are You a Good Fit for This Trial?

Inclusion Criteria

Symptomatic tracheal stenosis
Idiopathic subglottic stenosis
Iatrogenic tracheal stenosis from intubation or tracheostomy

Exclusion Criteria

Positive ANA or ANCA
Tracheal stenosis from infection, i.e. TB
Tracheal stenosis with cartilage fracture
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either CO2 laser wedge resection or radial incision with dilation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with endobronchial biopsies collected before and one month after intervention

2 years
Standardized clinical, physiologic, and imaging assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Radial Incision
  • Wedge Resection

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Carbon dioxide (CO2) laser wedge resectionExperimental Treatment1 Intervention
Group II: Radial incision and dilationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+