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Transcriptomic Profile Changes: CO2 Laser Wedge Resection vs Radial Incision for Benign Tracheal Stenosis

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Study Aim

This study aims to compare the changes in transcriptomic pathway activation scores between CO2 laser wedge resection and radial incision treatments for benign tracheal stenosis.

What is being tested

Bronchoscopy, carbon dioxide (CO2) laser wedge resection

+ Radial incision with dilation

Procedure
Who is being recruted

Respiratory Tract Diseases

+ Tracheal Diseases

+ Tracheal Stenosis

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2026
See protocol details

Summary

Principal SponsorUniversity of Maryland, Baltimore
Study ContactChenchen Zhang, MD
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2026

Actual date on which the first participant was enrolled.

Benign tracheal stenosis (BTS) is a rare but serious condition where the airway narrows due to scarring from causes like post-intubation or tracheostomy. The standard treatment involves bronchoscopic procedures, but recurrence rates are high and the best technique is uncertain. This study focuses on two common methods: carbon dioxide (CO₂) laser wedge resection and radial incision with dilation. While there's some evidence that wedge resection may have lower recurrence rates and longer recurrence-free intervals, the reasons behind this aren't fully understood. This research involves a randomized pilot study with 40 BTS patients, comparing the two methods. Before and one month after the procedure, endobronchial biopsies are collected and analyzed using bulk ribonucleic acid (RNA) sequencing and spatial transcriptomics. This dual approach helps map molecular pathways related to fibrosis resolution, immune cell dynamics, and epithelial repair. Patients are monitored for two years with standard clinical, physiologic, and imaging assessments. The molecular findings are then linked with recurrence-free survival and other significant outcomes. The aim is to fill critical knowledge gaps in understanding BTS management, potentially improving treatment selection and identifying new therapeutic targets to prevent recurrence.

Official TitleA Randomized Controlled Trial Comparing Transcriptomic Profile Changes Following Carbon Dioxide (CO2) Laser Wedge Resection Versus Radial Incision for Benign Tracheal Stenosis
Principal SponsorUniversity of Maryland, Baltimore
Study ContactChenchen Zhang, MD
Last updated: March 17, 2026
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

40 patients to be enrolled

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

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

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 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.

Conditions

Pathology

Respiratory Tract DiseasesTracheal DiseasesTracheal Stenosis

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

Study Plan

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

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary 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 1 location

Suspended

University of Maryland

Baltimore, United StatesOpen University of Maryland in Google Maps
Recruiting soonOne Study Center