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:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05714033
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia.
2. Lung nodules should be up to 3 cm in diameter and located in right or left bronchial segments B2, B6, B9, and B10. Greater than 50% of the volume of the lesion needs to be below a horizontal line traced at the most anterior edge of the corresponding vertebral body.
3. Chest CT performed \< 45 days prior to bronchoscopy.
4. Voluntary informed consent to participate in the study.
Exclusion Criteria:
1. Patients with prior lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) as seen on most recent CT
2. Lesions outside of the designated lung areas defined as inclusion criteria.
3. Known pregnancy
4. Vulnerable population
5. Ascites
6. Known diaphragmatic paralysis
7. Smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume \> 150% of predicted
8. History of primary or secondary spontaneous pneumothorax
9. Lung bullae \> 5 cm
10. Patients with mediastinal or hilar adenopathy with high suspicion for malignancy in whom lymph node sampling is indicated and should occur prior to robotic bronchoscopy of the peripheral lesion.
11. Patient with active COVID pneumonia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05714033
Study Brief:
Protocol Section:
NCT05714033