CT-Based Scoring System to Predict Surgical Need in Tracheal Stenosis (TSMAS Study) (NCT07086729) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CT-Based Scoring System to Predict Surgical Need in Tracheal Stenosis (TSMAS Study)
80 participantsStarted 2025-09-01
Plain-language summary
This study aims to develop a CT-based scoring system to help predict whether patients with tracheal stenosis will require surgical treatment or can be managed with endoscopic procedures. Using retrospective data, researchers will evaluate CT scans of patients diagnosed with tracheal stenosis to measure features such as airway diameter, wall thickness, and tissue density (measured in Hounsfield Units). The goal is to create a non-invasive, reproducible, and objective tool-called the Tracheal Stenosis Morphology and Attenuation Score (TSMAS)-that can support clinical decision-making and improve treatment planning.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosed with tracheal stenosis
* Underwent thoracic CT imaging at the time of diagnosis
* CT scans available in adequate quality and in DICOM format
* No prior surgical treatment for tracheal stenosis before CT imaging
Exclusion Criteria:
* Tracheal stenosis due to malignancy, foreign body, or tracheobronchial tumors
* History of tracheal surgery before CT imaging
* Poor quality CT images (e.g., motion artifacts, incomplete tracheal segments)
* Patients with a history of radiotherapy (RT) to the neck or mediastinum
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT
Timeframe: From initial diagnosis to surgical decision (up to 12 months)
2
Prediction of Surgical Requirement Based on Tracheal Wall Thickness on Initial CT
Timeframe: From initial diagnosis to surgical decision (up to 12 months)
3
Prediction of Surgical Requirement Based on HU Values of the Stenotic Segment on CT
Timeframe: From initial diagnosis to surgical decision (up to 12 months)