Tracheal StenosisNCT07086729
CT-Based Scoring System to Predict Surgical Need in Tracheal Stenosis (TSMAS Study)
An observational study of Tracheal Stenosis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- CT-Based Morphologic and Attenuation Scoring
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 and older) diagnosed with tracheal stenosis, who underwent thoracic CT imaging at the time of diagnosis. All patients were treated or followed at Ondokuz Mayıs University Hospital between 2000 and 2025. Only patients with sufficient-quality DICOM-format CT scans and no prior tracheal surgery or radiotherapy were included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Faculty of Medicine
Samsun
About this study
Official title: Development of a CT-Derived Risk Score to Guide Treatment Decision: Tracheal Stenosis Morphology and Attenuation Score (TSMAS)
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.
- Conditions
- Tracheal Stenosis
- Being tested
- CT-Based Morphologic and Attenuation Scoring
- Keywords
- Tracheal Stenosis, Postintubation Stenosis, Hounsfield Unit, Morphologic Scoring, Computed Tomography
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Based Morphologic and Attenuation ScoringOther
Retrospective analysis of CT images to extract morphological and Hounsfield Unit (HU) parameters for development of a predictive scoring model (TSMAS). No clinical or therapeutic intervention was performed.
| Study group | Role | What they receive |
|---|---|---|
| Tracheal Stenosis Patients | Patients diagnosed with tracheal stenosis whose thoracic CT scans were retrospectively analyzed to evaluate morphological and densitometric parameters. No intervention was applied; data were used to develop a CT-based risk score (TSMAS) to predict the need for surgical treatment. Receives: Other: CT-Based Morphologic and Attenuation Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT
Evaluation of whether smaller tracheal diameter on initial CT is associated with need for surgery.
Unit of Measure: millimeters
Measured: From initial diagnosis to surgical decision (up to 12 months)
Prediction of Surgical Requirement Based on Tracheal Wall Thickness on Initial CT
Evaluation of whether increased tracheal wall thickness on initial CT predicts surgical need.
Unit of Measure: millimeters
Measured: From initial diagnosis to surgical decision (up to 12 months)
Prediction of Surgical Requirement Based on HU Values of the Stenotic Segment on CT
Evaluation of whether high HU values in the stenotic segment predict surgical need.
Unit of Measure: Hounsfield Units (HU)
Measured: From initial diagnosis to surgical decision (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086729
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/ 457
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a CT-Derived Risk Score to Guide Treatment Decision: Tracheal Stenosis Morphology and Attenuation Score (TSMAS)
- ClinicalTrials.gov ID
- NCT07086729
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/ 457
- Conditions
- Tracheal Stenosis
- Keywords
- Tracheal Stenosis, Postintubation Stenosis, Hounsfield Unit, Morphologic Scoring, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheal Stenosis Patients | – | Other: CT-Based Morphologic and Attenuation ScoringPatients diagnosed with tracheal stenosis whose thoracic CT scans were retrospectively analyzed to evaluate morphological and densitometric parameters. No intervention was applied; data were used to develop a CT-based risk score (TSMAS) to predict the need for surgical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 and older) diagnosed with tracheal stenosis, who underwent thoracic CT imaging at the time of diagnosis. All patients were treated or followed at Ondokuz Mayıs University Hospital between 2000 and 2025. Only patients with sufficient-quality DICOM-format CT scans and no prior tracheal surgery or radiotherapy were included.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-Based Morphologic and Attenuation ScoringRetrospective analysis of CT images to extract morphological and Hounsfield Unit (HU) parameters for development of a predictive scoring model (TSMAS). No clinical or therapeutic intervention was performed. | Other | Tracheal Stenosis Patients |
Primary outcome
Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT
Time frame: From initial diagnosis to surgical decision (up to 12 months)
Evaluation of whether smaller tracheal diameter on initial CT is associated with need for surgery. Unit of Measure: millimeters
Prediction of Surgical Requirement Based on Tracheal Wall Thickness on Initial CT
Time frame: From initial diagnosis to surgical decision (up to 12 months)
Evaluation of whether increased tracheal wall thickness on initial CT predicts surgical need. Unit of Measure: millimeters
Prediction of Surgical Requirement Based on HU Values of the Stenotic Segment on CT
Time frame: From initial diagnosis to surgical decision (up to 12 months)
Evaluation of whether high HU values in the stenotic segment predict surgical need. Unit of Measure: Hounsfield Units (HU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Stenosis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT (time frame: From initial diagnosis to surgical decision (up to 12 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.