An interventional study of Cryopreserved aorta in Trachea Diseases, Tracheal Stenosis and Tuberculosis; Tracheitis, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.
This trial plans to use cryopreserved donor aortic tissue patches to repair and treat pediatric patients with end-stage, life-threatening or severely disabling tracheal diseases who have not responded to conventional conservative therapies or lack sufficient native tracheal tissue for tracheal defect reconstruction.
42 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.
This study's planned enrollment of 5 is below the median of 22 across 24 interventional studies indexed under Tracheal Stenosis.
Browse Tracheal Stenosis studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Compared within Tracheal Stenosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tracheal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meeting any of the following conditions, and being unsuitable for standard end-to-end tracheal anastomosis or lacking sufficient native tracheal tissue for defect reconstruction:
The term "severe clinical respiratory symptoms" includes:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After resection of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.
Procedure: Cryopreserved aorta
After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment of human cryopreserved (-80 celsius degree) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. The anastomosis is performed with standard technique for airway anastomosis.
90-day Mortality
Survival status of patients within 90 days after surgery. This primary endpoint evaluates patient mortality, as patients undergoing this type of surgery often have a high short-term risk of death.
Time frame: Postoperative 90 days
Anastomotic Leakage
Incidence of anastomotic leakage at the tracheal anastomosis site.
Time frame: Within 90 days postoperatively
Pneumonia
Incidence of postoperative pneumonia.
Time frame: Within 90 days postoperatively
Difficult Extubation
Occurrence of difficulties in extubation after surgery.
Time frame: Within 90 days postoperatively
Granulation Tissue Obstruction
Incidence of airway obstruction due to granulation tissue formation.
Time frame: Within 90 days postoperatively
Stenosis Caused by Scar Fibrosis and Related Complications
Occurrence of airway stenosis due to scar fibrosis or other related complications.
Time frame: Within 90 days postoperatively
Long-term Clinical Follow-up
Patients will undergo long-term follow-up including medical history review, physical examination, and imaging studies as clinically indicated (including but not limited to X-ray, CT scan, and bronchoscopy) to monitor long-term airway status and overall health.
Time frame: At least 1 year postoperatively; infants and young children followed until at least puberty
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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