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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03414905
Eligibility Criteria:
Inclusion Criteria:
* Male or female, at least 18 years of age, inclusive
* Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true
* There is cytological confirmation of pleural malignancy
* The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein \>0.5, Pleural fluid LDH/Serum LDH \>0.6, or Pleural fluid LDH \>2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
* Subject is able to provide informed consent
* Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
* Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).
Exclusion Criteria:
* Subject is pregnant
* Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
* Subjects with uncorrected coagulopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03414905
Study Brief:
Protocol Section:
NCT03414905