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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02464904
Eligibility Criteria:
Inclusion Criteria
* Subject provides informed consent
* Subject is \>18 years of age
* Subject is deemed competent for making medical decisions
* Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma
* A negative pregnancy test is required in women of child-bearing potential, as standard of care.
* Subject is mentally capable of understanding study procedures.
Exclusion Criteria
Study subject has any disease or condition that interferes with safe completion of the study including:
* Platelet count \< 50K, coagulopathy defined as an International Normalized Ratio (INR) \> 1.5
* Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published
* Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians.
* Hypoxemia with pulse oximetry values \<88% or partial pressure of oxygen in arterial blood (PaO2) \< 60 on baseline oxygen requirements.
* Concurrent participation in another study involving investigational drugs or investigational medical devices
* Absence of or limited access to the pleural space during medical pleuroscopy.
* Inability to read and understand the necessary study documents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02464904
Study Brief:
Protocol Section:
NCT02464904