Trachea DiseasesNCT07240259
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
A study testing Cryopreserved aorta in people with Trachea Diseases and Tracheal Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Trachea Diseases, Tracheal Stenosis, Tuberculosis; Tracheitis
- What is being tested?
- Cryopreserved aorta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
- Congenital tracheal malformations: including congenital tracheomalacia, congenital tracheobronchial anomalies, complete tracheal rings, etc., with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- Acquired tracheal stenosis: including tracheal narrowing caused by disease, endotracheal intubation, or postoperative scar formation, with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- Tracheal injury or tissue loss due to trauma or burns requiring surgical repair.
- Tracheal tumors: reconstruction of tracheal tissue after resection of benign or malignant tumors.
- The term "severe clinical respiratory symptoms" includes:
Show all 10Show fewer
- Dependence on mechanical ventilation for more than 1 month due to airway narrowing or defect, with inability to wean.
- Airway stenosis exceeding 50% (confirmed by bronchoscopy or CT imaging), accompanied by persistent stridor, inspiratory dyspnea, or suprasternal/substernal retractions, causing impairment of daily activities or feeding difficulties.
- Unilateral or bilateral lung atelectasis persisting for more than 1 month due to tracheal or bronchial stenosis, with no sign of recovery.
- Recurrent post-obstructive pneumonia (≥3 episodes) in one or both lungs caused by tracheal or bronchial stenosis, requiring hospitalization for treatment.
Who cannot join
- Inability to obtain legal informed consent from the lawful guardian.
- Locally invasive tracheal tumors that cannot be completely resected surgically.
- Malignant solid tumors with distant metastases that cannot be completely resected surgically or controlled with medication.
- Presence of severe immunodeficiency (e.g., congenital immunodeficiency, HIV infection, ongoing chemotherapy, or recovery period after bone marrow transplantation).
- Presence of major congenital diseases or chromosomal abnormalities (e.g., Trisomy 13, Trisomy 18) with extremely poor prognosis as assessed clinically.
- End-stage organ failure (e.g., persistent multiple organ failure, irreversible cardiopulmonary failure, or brain death).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.
Read the detailed description
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.
- Conditions
- Trachea Diseases, Tracheal Stenosis, Tuberculosis; Tracheitis, Airway Disease, Tracheomalacia, Tracheal Stenosis Following Tracheostomy
- Being tested
- Cryopreserved aorta
- Keywords
- tracheomalacia, bronchial reconstruction, cryopreserved aorta, tracheal reconstruction, tracheal stenosis
- Medical subject headings
- Tracheal Diseases, Tracheal Stenosis, Tuberculosis, Tracheitis, Tracheomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved aortaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryopreserved aorta | Experimental | After resection of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft. Receives: Procedure: Cryopreserved aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 90 days
Secondary outcomes (5)
Anastomotic Leakage
Incidence of anastomotic leakage at the tracheal anastomosis site.
Measured: Within 90 days postoperatively
Pneumonia
Incidence of postoperative pneumonia.
Measured: Within 90 days postoperatively
Difficult Extubation
Occurrence of difficulties in extubation after surgery.
Measured: Within 90 days postoperatively
Granulation Tissue Obstruction
Incidence of airway obstruction due to granulation tissue formation.
Measured: Within 90 days postoperatively
Stenosis Caused by Scar Fibrosis and Related Complications
Occurrence of airway stenosis due to scar fibrosis or other related complications.
Measured: Within 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trachea DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240259
- Sponsor's protocol ID
- 202404094DINC
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsou KC, Hung WT, Ju YT, Liao HC, Hsu HH, Chen JS. Application of aortic allograft in trachea transplantation. J Formos Med Assoc. 2023 Sep;122(9):940-946. doi: 10.1016/j.jfma.2023.03.006. Epub 2023 Mar 29.
PubMed 37002174Lu CW, Liao HC, Tsou KC, Hung WT, Huang PM, Hsu HH, Chen JS. Cryopreserved aortic graft patch repair of traumatic tracheal rupture defect: A case report. JTCVS Tech. 2024 Aug 17;27:182-184. doi: 10.1016/j.xjtc.2024.07.023. eCollection 2024 Oct. No abstract available.
PubMed 39478918Hung WT, Liao HC, Hsu HH, Chen JS. Stented cryopreserved aortic allograft for reconstruction of long-segment post-tuberculosis tracheal stenosis. J Formos Med Assoc. 2024 Jul;123(7):818-820. doi: 10.1016/j.jfma.2024.03.006. Epub 2024 Mar 16.
PubMed 38494361
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
- ClinicalTrials.gov ID
- NCT07240259
- Acronym / sponsor ID
- 202404094DINC
- Conditions
- Trachea Diseases, Tracheal Stenosis, Tuberculosis; Tracheitis, Airway Disease, Tracheomalacia, Tracheal Stenosis Following Tracheostomy
- Keywords
- tracheomalacia, bronchial reconstruction, cryopreserved aorta, tracheal reconstruction, tracheal stenosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 20 Nov 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.
Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryopreserved aorta | Experimental | Procedure: Cryopreserved aortaAfter resection of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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:
- Congenital tracheal malformations: including congenital tracheomalacia, congenital tracheobronchial anomalies, complete tracheal rings, etc., with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- Acquired tracheal stenosis: including tracheal narrowing caused by disease, endotracheal intubation, or postoperative scar formation, with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- Tracheal injury or tissue loss due to trauma or burns requiring surgical repair.
- Tracheal tumors: reconstruction of tracheal tissue after resection of benign or malignant tumors.
Key exclusion criteria (6 listed)
- Inability to obtain legal informed consent from the lawful guardian.
- Locally invasive tracheal tumors that cannot be completely resected surgically.
- Malignant solid tumors with distant metastases that cannot be completely resected surgically or controlled with medication.
- Presence of severe immunodeficiency (e.g., congenital immunodeficiency, HIV infection, ongoing chemotherapy, or recovery period after bone marrow transplantation).
- Presence of major congenital diseases or chromosomal abnormalities (e.g., Trisomy 13, Trisomy 18) with extremely poor prognosis as assessed clinically.
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 |
|---|---|---|
| Cryopreserved aortaAfter 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. | Procedure or surgery | Cryopreserved aorta |
Primary outcome
90-day Mortality
Time frame: Postoperative 90 days
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.
5 secondary outcomes
Anastomotic Leakage
Time frame: Within 90 days postoperatively
Pneumonia
Time frame: Within 90 days postoperatively
Difficult Extubation
Time frame: Within 90 days postoperatively
Granulation Tissue Obstruction
Time frame: Within 90 days postoperatively
Stenosis Caused by Scar Fibrosis and Related Complications
Time frame: Within 90 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 37002174Tsou KC, Hung WT, Ju YT, Liao HC, Hsu HH, Chen JS. Application of aortic allograft in trachea transplantation. J Formos Med Assoc. 2023 Sep;122(9):940-946. doi: 10.1016/j.jfma.2023.03.006. Epub 2023 Mar 29.
- Background: PubMed 39478918Lu CW, Liao HC, Tsou KC, Hung WT, Huang PM, Hsu HH, Chen JS. Cryopreserved aortic graft patch repair of traumatic tracheal rupture defect: A case report. JTCVS Tech. 2024 Aug 17;27:182-184. doi: 10.1016/j.xjtc.2024.07.023. eCollection 2024 Oct. No abstract available.
- Background: PubMed 38494361Hung WT, Liao HC, Hsu HH, Chen JS. Stented cryopreserved aortic allograft for reconstruction of long-segment post-tuberculosis tracheal stenosis. J Formos Med Assoc. 2024 Jul;123(7):818-820. doi: 10.1016/j.jfma.2024.03.006. Epub 2024 Mar 16.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Cryopreserved aorta in people with Trachea Diseases and Tracheal Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 10 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 17 Aug 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
90-day Mortality (time frame: Postoperative 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240259, which also lists 3 linked publications.
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 17 Aug 2026.