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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Repairing tracheal and bronchial defects with a donated cryopreserved aortic patch

Official title: Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

Run by National Taiwan University Hospital · NCT06935110 · Data updated 2026-11-12

This test tries a donated cryopreserved aortic patch to repair tracheal or bronchial defects in people who need airway reconstruction after congenital problems, injury, or tumor removal.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorNational Taiwan University Hospital
Academic / other
Locations2 sites (Taipei and 1 other locations)
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedJuly 31, 2029
Study endsOctober 2029
Registry record updatedJune 12, 2026
Trial IDNCT06935110 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults or children with severe tracheal or bronchial defects from congenital malformations, post-intubation or disease-related stenosis, trauma or burns, or tissue loss after tumor removal who are recommended for surgical repair and can provide consent.

Probably not a fit

Patients with unresectable locally invasive tumors, contralateral lymph node involvement, distant metastases (except solitary resectable brain lesions), those who can be treated with standard lobectomy, or who cannot give informed consent are unlikely to benefit from this procedure.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional program uses cryopreserved donor aortic patches as graft material to reconstruct defects of the trachea or bronchi. Eligible patients include those with severe congenital tracheal deformities, acquired tracheal stenosis, traumatic or burn-related airway defects, or tissue loss after tumor resection. Surgical implantation of the aortic patch will be followed by clinical assessment, imaging, and bronchoscopic exams to monitor healing, airway patency, and complications. The primary aim is to establish the safety and technical feasibility of this repair approach at National Taiwan University Hospital in Taipei.

Why it matters

Potential benefit: If successful, this approach could provide an alternative graft material to restore airway continuity and avoid more extensive reconstruction procedures.

How similar studies have gone: Use of cryopreserved vascular or aortic patches for airway reconstruction has appeared in limited case reports and small series with promising but preliminary results, so the approach remains relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • National Taiwan University Hospital
    Taipei, Taiwan     Recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan     Not yet recruiting

Study contacts

  • Principal investigator: Jin-Shing Chen, MD, PhD — National Taiwan University Hospital, Taipei, 100
  • Study coordinator: Chao-Wen Lu, MD
  • Email: i2363160@gmail.com
  • Phone: +886972652324

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.