Recruiting

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT07463742

Conditions

Tracheal Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bronchoscopy, carbon dioxide (CO2) laser wedge resection

Radial incision with dilation

Study Details

Brief summary:

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.

Conditions

Tracheal Stenosis

Study ID

NCT07463742

Start date

May 1, 2026

Status verified date

Aug, 2026

Completion date

May 1, 2032

Anticipated

Primary completion date

May 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Carbon dioxide (CO2) laser wedge resection

active comparator: Radial incision and dilation

Interventions

Bronchoscopy, carbon dioxide (CO2) laser wedge resection

CO2 laser wedge resection - removing scar tissue with laser, leading tissue bridges.

Radial incision with dilation

Radial incision with dilation - making radial cuts at the circumferential scar site, followed by balloon dilation.

Primary outcome measure

  • Change in transcriptomic pathway activation scores [ Time Frame: at the time of the second procedure (1 month from the initial invervention) ]

Central Contacts and Locations

Central contacts

Chenchen Zhang, MD

410-328-8138chenchen.zhang@som.umaryland.edu

Locations

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21021

Contacts

Chenchen Zhang, MD

410-328-8138chenchen.zhang@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • tracheal stenosis
  • bronchoscopy
  • wedge resection
  • CO2 laser

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-08-20.