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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07331805
Eligibility Criteria:
Inclusion Criteria:
* Age: \>18 and ≤60 years at the time of enrollment.
* Diagnosis: Primary spontaneous pneumothorax of large size (lung collapse ≥30% by the Collins method on chest X-ray).
* Episode type: Any episode of primary spontaneous pneumothorax.
* Clinical stability suitable for observation without immediate intervention: Systolic BP \>90 mmHg, heart rate \<140 bpm, oxygen saturation \>90% (with supplemental oxygen if needed), respiratory rate 15-30 breaths/min.
* Consent: Has read and understood the participant information sheet and signed informed consent.
Exclusion Criteria:
* Pre-existing lung disease that may predispose to pneumothorax (e.g., COPD, cystic fibrosis, interstitial lung disease, tuberculosis, pulmonary neoplasm).
* Indication for urgent thoracic surgery (e.g., imaging highly suggestive of giant bullae/blebs requiring immediate surgical intervention).
* Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07331805
Study Brief:
Protocol Section:
NCT07331805