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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT06380361
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years
2. Subjects with lesions eligible for lung biopsy under general anesthesia.
3. Lesion localization:
1. Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or
2. Peripheral lesions ≥ 20 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or ultrasound analysis (RP EBUS with central localization of the ultrasound probe) during the procedure.
4. Written Informed Consent to participate in the study.
Exclusion Criteria:
1. Target lesion \<10 mm for central and \<20 mm for peripheral lesions (as determined on previous imaging)
2. Contra-indication to bronchoscopy procedures
3. Contra-indication to general anesthesia
4. Any subject that is, according to the discretion of the investigator, not eligible for study participation
5. Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06380361
Study Brief:
Protocol Section:
NCT06380361