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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT04758403
Eligibility Criteria:
Inclusion Criteria:
* Participants ≥18 years old.
* Participants with lesions having an intermediate pre-test probability of malignancy (pCA, 0.05 to 0.65) as determined by Swensen-Mayo nodule risk calculator and in whom bronchoscopic biopsy was determined to be the next best treatment step by the treating pulmonologist.
* Participants with higher risk lesions (pCA \> 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery.
* Participants are willing and able to provide informed consent.
Exclusion Criteria:
* The participant is pregnant as confirmed by urine or serum pregnancy testing.
* There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in participant's with a nodule in the outer 1/3 lung zone (i.e. The participant would not go on for a CT guided TTNA).
* Lacked fitness according to physician judgement to undergo bronchoscopy.
* Contraindication for temporary interruption of the use of anticoagulant therapy.
* Uncontrolled or irreversible coagulopathy.
* Known allergy for lidocaine.
* Uncontrolled pulmonary hypertension.
* Recent (\< 4 weeks) and/or uncontrolled cardiac disease.
* Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis such that endobronchial access is considered unsafe).
* ASA classification ≥ 4.
* COVID-19 positive participant at the time of procedure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04758403
Study Brief:
Protocol Section:
NCT04758403