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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT05270850
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged between 18 to 75
* Subjects diagnosed with benign airway stenosis, tracheoesophageal fistula(the sizes of the fistulas less than 2cm), and bronchopleural fistula
* Subjects willing to accept SVF treatment
* Subjects tolerant to the bronchoscope
* Subjects signed informed consent
Exclusion Criteria:
* Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc;
* Subjects with incomplete remission of malignant tumors or with incurable malignant tumors;
* Subjects with uncontrolled systemic infection;
* Subjects requiring anti-clotting drugs;
* Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc;
* Subjects with syphilis, HIV, HBV, HCV antibody positive;
* Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc;
* Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value;
* Subjects with liver disease or liver damage: ALT, AST, total bilirubin \> 2 times the upper limit of the normal value;
* Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases;
* Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction;
* Subjects allergic to thrombin;
* Subjects accepted by any other clinical study within the first three months of the study;
* Subjects with poor compliance;
* Any other conditions might increase the risk of the patient or interfere with the clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05270850
Study Brief:
Protocol Section:
NCT05270850