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 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT03325192
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of MPE as defined by
1. A diagnosis a pleural effusion in the setting of known malignancy. AND
2. Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR
3. Evidence of pleural disease on radiographic imaging. OR
4. A recurrent effusion with no other identifiable cause after thorough workup.
2. Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
3. Prior thoracentesis with post procedure symptomatic relief
4. Recurrence of symptoms with re-accumulation of pleural effusion
5. Lung re-expansion after thoracentesis on chest imaging within last 30 days
Exclusion Criteria:
1. Malignant pleural effusion due to a hematologic malignancy
2. ECOG \>4
3. Any history of trapped lung
4. Prior attempted pleurodesis on the affected site
5. Age \<18
6. Pregnant or lactating
7. Known allergy to iodopovidone (Betadine)
8. Unable or unwilling to provide consent
9. Uncorrectable coagulopathy (INR \> 1.5, aPTT \> 1.5 x the upper limit of normal) or thrombocytopenia (\< 50,000)
10. Anatomic contraindication to IPC (overlying skin abnormalities)
11. Unable or unwilling to care for IPC and adhere to drainage protocol
12. Need for bilateral IPC placement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03325192
Study Brief:
Protocol Section:
NCT03325192