Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT07240259
Eligibility Criteria:
Inclusion Criteria:
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:
1. Congenital tracheal malformations: including congenital tracheomalacia, congenital tracheobronchial anomalies, complete tracheal rings, etc., with severe clinical respiratory symptoms and recommended for treatment after evaluation.
2. 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.
3. Tracheal injury or tissue loss due to trauma or burns requiring surgical repair.
4. Tracheal tumors: reconstruction of tracheal tissue after resection of benign or malignant tumors.
5. The term "severe clinical respiratory symptoms" includes:
1. Dependence on mechanical ventilation for more than 1 month due to airway narrowing or defect, with inability to wean.
2. 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.
3. Unilateral or bilateral lung atelectasis persisting for more than 1 month due to tracheal or bronchial stenosis, with no sign of recovery.
4. Recurrent post-obstructive pneumonia (≥3 episodes) in one or both lungs caused by tracheal or bronchial stenosis, requiring hospitalization for treatment.
Exclusion Criteria:
1. Inability to obtain legal informed consent from the lawful guardian.
2. Locally invasive tracheal tumors that cannot be completely resected surgically.
3. Malignant solid tumors with distant metastases that cannot be completely resected surgically or controlled with medication.
4. Presence of severe immunodeficiency (e.g., congenital immunodeficiency, HIV infection, ongoing chemotherapy, or recovery period after bone marrow transplantation).
5. Presence of major congenital diseases or chromosomal abnormalities (e.g., Trisomy 13, Trisomy 18) with extremely poor prognosis as assessed clinically.
6. End-stage organ failure (e.g., persistent multiple organ failure, irreversible cardiopulmonary failure, or brain death).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT07240259
Study Brief:
Protocol Section:
NCT07240259