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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT02961335
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 18
* signed written informed consent
* indication for a flexible bronchoscopy
* DPLD characterized by clinical and radiological data compatible with : idiopathic pulmonary fibrosis (IPF), acute or chronic hypersensitivity pneumonitis (HPS), sarcoidosis, or asbestosis.
* Initial histological confirmation of the disease is not required for the inclusion of the patient and the realisation of the alveolar bronchoscopy.
* non-smoking or smoking cessation \>6 month
* Patient affiliated with, or beneficiary of a social security category
Exclusion Criteria:
* respiratory failure and contraindication for a flexible bronchoscopy (this item will stay at the appreciation of the physician, arterial blood gaz sampling being not required)
* bleeding disorder which would be not compatible with the realization of a flexible bronchoscopy
* history of pneumonectomy or non functional lung controlateral to the pCLE procedure
* patients for which a per-endoscopic distal lung cryobiopsy is forecasted during the first diagnostic bronchoscopy,
* patients for which the bronchoscopy needs a general anesthesia and mechanical ventilation during the procedure
* anticoagulant or platelet aggregation inhibitors that cannot be interrupted for the flexible bronchoscopy
* patients for which a follow up or an adequate work-up to achieve the final diagnosis will not be possible.
* patients for which a cryobiopsy is forecasted during the bronchoscopy
* pregnant and breast feeding women, or women of childbearing potential not taking adequate contraception
* Patients unable to understand informed consent
* Patient on major legal measure of protection
* Patients participating in an other interventional clinical trial at the inclusion date
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02961335
Study Brief:
Protocol Section:
NCT02961335