Biopsy-based test to compare wedge resection vs. radial incision for benign tracheal narrowing
Official title: A Randomized Controlled Trial Comparing Transcriptomic Profile Changes Following Carbon Dioxide (CO2) Laser Wedge Resection Versus Radial Incision for Benign Tracheal Stenosis
Run by University of Maryland, Baltimore · NCT07463742 · Data updated 2026-11-12
This study tests two airway-opening techniques in people with benign tracheal stenosis to see how their airway tissue changes after treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | May 1, 2031 |
| Study ends | May 1, 2032 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07463742 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with symptomatic, idiopathic or iatrogenic tracheal stenosis eligible for bronchoscopy and either wedge resection or radial incision with dilation.
✕Probably not a fit
Patients with non-benign causes or contraindications to bronchoscopy or the studied interventions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized pilot study compares CO2 laser wedge resection with radial incision plus dilation in patients with benign tracheal stenosis. Tissue samples are collected before and one month after the procedures and analyzed with bulk RNA sequencing and spatial transcriptomics to map gene-expression changes related to fibrosis, immune response, and airway repair. Participants are followed for two years with clinical, physiologic, and imaging assessments to relate molecular findings to recurrence-free survival and other outcomes. The trial aims to illuminate biological mechanisms that may explain differences in recurrence and guide future treatment refinements.
Why it matters
Potential benefit: If successful, the study could reveal molecular markers and pathways that predict better outcomes and help tailor treatments for BTS.
How similar studies have gone: Prior evidence suggests potential differences between wedge resection and radial incision, but direct randomized comparison with molecular endpoints is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * tracheal stenosis with malacia * tracheal stenosis from malignancy * tracheal stenosis from benign tumor * presence of glottic or supraglottic stenosis
Where it's running
-
University of Maryland
Baltimore, Maryland, United States Recruiting
Study contacts
- Study coordinator: Chenchen Zhang, MD
- Email: chenchen.zhang@som.umaryland.edu
- Phone: 410-328-8138
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.