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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT00761618
Eligibility Criteria:
Inclusion Criteria:
1. Patients with symptomatic pleural effusion requiring placement of an IPC.
2. Signed informed consent prior to any study related procedures.
3. Subject must be age 18 years or over.
Exclusion Criteria:
1. Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.
2. Evidence of empyema or history of empyema of the affected hemithorax
3. Non-correctable bleeding diathesis
4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
5. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
6. Participation in any clinical trial that prevents randomization of the subject to either strategy.
7. Clinical evidence of skin infection at the potential site of IPC placement.
8. Current or prior IPC placement, or any intervention to manage recurrent malignant pleural effusion on the contralateral hemithorax (excluding thoracentesis).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00761618
Study Brief:
Protocol Section:
NCT00761618