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Donated aortic patches could fix windpipe damage in small trial

NCT ID NCT06935110

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using cryopreserved aortic patches (donated tissue) can safely repair defects in the windpipe or bronchial tubes. Ten people with severe tracheal narrowing or deformities will receive this surgical patch. The main goal is to see if it reduces death and complications like leaks or blockages within 90 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Congenital tracheal deformities: Includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation. 2. Acquired tracheal stenosis: Includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation. 3. Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair. 4. Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors. Exclusion Criteria: 1. Patients who are unable to provide informed consent. 2. Pulmonary tumors that can be treated with standard lobectomy. 3. Locally invasive tumors that are unresectable. 4. Presence of contralateral lymph node metastasis. 5. Presence of distant metastasis, except for solitary, resectable brain metastasis. 6. Tracheal lesions amenable to standard resection with direct anastomosis. 7. Preoperative evaluation indicates inability to undergo standard lobectomy. 8. Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders. 9. Any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy). 10. Individuals with concerns about the potential risks of the trial.

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Conditions

The condition(s) this trial relates to.

Airway Remodeling congenital tracheomalacia injury trachea leiomyoma tracheal disorder tracheal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Airway remodeling Reconstruction surgery Trachea diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Taiwan University Hospital

    NOT_YET_RECRUITING

    Taipei, 100, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

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