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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT01952327
Eligibility Criteria:
Inclusion Criteria:
1. \> 18 years of age
2. Recurrent pleural effusion due malignancy Malignant pleural effusions are defined as either Fluid in the context of histocytologically confirmed pleural malignancy, or pleural fluid in the context of histocytologically confirmed malignancy elsewhere, with no other clear cause for the effusion.
3. 1 or more therapeutic procedures for pleural fluid drainage prior to enrolment.
4. Written informed consent
5. Ability to comply with study procedures and ability to operate the device
6. Expected survival of more than 3 months after device insertion
Exclusion Criteria:
1. Haemothorax
2. Purulent pleural effusion
3. Significant pleural fluid septation or loculation on thoracic ultrasound or cross-sectional imaging
4. Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
5. Pregnant females or females anticipating pregnancy during study period.
6. Patients currently enrolled in another interventional clinical study
7. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardioverter defibrillator.
8. Major comorbidity which, in the opinion of the principal investigator, is likely to significantly decrease life expectancy, increase anaesthetic risk, or lead to device removal (e.g. moderate to severe congestive heart failure, significant valvular heart disease, persistent immunosuppression, etc.)
9. Other contraindication to general anaesthesia
10. Other contraindication to procedure (e.g. uncorrectable bleeding diathesis, infection or malignant involvement over proposed insertion site)
11. Significant renal impairment, as determined by the principal investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01952327
Study Brief:
Protocol Section:
NCT01952327