An interventional study of Bronchoscopy, carbon dioxide (CO2) laser wedge resection and Radial incision with dilation in Tracheal Stenosis, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
Benign tracheal stenosis (BTS) is an uncommon but potentially life-threatening condition caused by fibroinflammatory scarring that narrows the airway. Etiologies include post-intubation, tracheostomy, and idiopathic disease. Bronchoscopic intervention is the first-line treatment; however, recurrence rates exceed 50%, and the optimal technique remains uncertain. Two widely used modalities-carbon dioxide (CO₂) laser wedge resection and radial incision with dilation-have never been directly compared in a randomized trial. Preliminary evidence, including our meta-analysis, suggests wedge resection may yield lower recurrence rates and longer recurrence-free intervals, but the biological mechanisms underlying these differences remain unknown.
This project will conduct a randomized pilot study of 40 BTS patients comparing CO₂ laser wedge resection and radial incision with dilation. Endobronchial biopsies will be collected before and one month after intervention and analyzed using bulk ribonucleic acid (RNA) sequencing and spatial transcriptomics to capture both global and spatially resolved gene expression changes. This dual-modality approach will map molecular pathways involved in fibrosis resolution, immune cell dynamics, and epithelial repair. Patients will be followed for two years with standardized clinical, physiologic, and imaging assessments, and molecular signatures will be correlated with recurrence-free survival and other clinically meaningful outcomes.
By combining prospective clinical data with high-resolution transcriptomic profiling, this study addresses critical gaps in mechanistic understanding and comparative effectiveness evidence for BTS management. The findings will establish a biologic framework for selecting optimal bronchoscopic approaches, identify candidate therapeutic targets to prevent recurrence, and generate effect-size estimates to power a future multicenter randomized controlled trial.
42 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.
This study's planned enrollment of 40 is above the median of 22 across 24 interventional studies indexed under Tracheal Stenosis.
Browse Tracheal Stenosis studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Bronchoscopy, carbon dioxide (CO2) laser wedge resection
Procedure: Radial incision with dilation
CO2 laser wedge resection - removing scar tissue with laser, leading tissue bridges.
Radial incision with dilation - making radial cuts at the circumferential scar site, followed by balloon dilation.
Change in transcriptomic pathway activation scores
Time frame: at the time of the second procedure (1 month from the initial invervention)
Plan to share: Yes — Individual participant data (IPD) from this study will be shared in a de-identified form for research purposes only, consistent with participant confidentiality protections. The shared dataset will include: Clinical data: age, sex, relevant medical history related to benign tracheal stenosis, treatment type (CO₂ laser wedge resection vs. radial incision with dilation), recurrence status, symptom scores, spirometry results (PIF, PEF), and imaging findings. Transcriptomic data: bulk RNA-seq and spatial RNA-seq gene expression data from pre- and post-treatment tissue samples, without any personally identifiable information. Exclusions: No names, initials, dates of birth, social security numbers, or other direct identifiers will be shared. All samples and data will be linked only by unique study codes. Intended Use: Shared data will be available to qualified researchers for secondary analyses of benign tracheal stenosis or related molecular research, in accordance with institutional an
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: 5/1/2026 to 5/1/2036
Access criteria: Who can access: Only qualified researchers who have submitted a request and agreed to the terms of use, including confidentiality and data security requirements, will have access to the shared IPD. These researchers must be affiliated with an academic, clinical, or research institution. What they can access: De-identified datasets including clinical data (age, sex, medical history, treatment type, recurrence status, symptom scores, spirometry, imaging) and transcriptomic data (bulk RNA-seq and spatial RNA-seq). No personally identifiable information (names, initials, dates of birth, social security numbers) will be included. How they can access: Access will be provided through a secure, password-protected database or data repository approved by the institution. Researchers must complete a data use agreement specifying that data are for research purposes only and will not be shared further.
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