Talc Outpatient Pleurodesis With Indwelling Catheter
Status unconfirmed · Not applicable
Conditions studied: Pleural Effusion, Pleural Diseases, Malignant Pleural Effusion
In brief
This study will be a prospective, randomized trial comparing a new protocol to the standard of care. The investigators protocol and the standard of care involves a previously established procedure that will be completed in the investigators pulmonary procedure unit. The study will include using previously, well-established procedures (indwelling pleural catheter placement, talc slurry administration through an indwelling pleural catheter, pleuroscopy with talc poudrage administration) in addition to a new protocol (at home continuous drainage via indwelling pleural catheter).
Key facts
- Study ID
- NCT03973957
- Run by
- The Cooper Health System
- People needed
- 124
- Starts
- 2019-05-27
- Expected to finish
- 2021-01-31
- Last updated by the study team
- 2019-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age greater than or equal to 18 years old
- Diagnosis of a paramalignant pleural effusion (defined as a recurrent pleural effusion directly caused by malignancy with known thoracic involvement)
- Estimated life expectancy greater than 3 months
- Full lung re-expansion on chest x-ray after thoracentesis
You may not qualify if…
- Age less than 18 years old
- Pregnant or lactating subject
- Any history of prior pleural talc administration
- History of an indwelling pleural catheter placed on the side of the active paramalignant pleural effusion
- Estimated life expectancy less than 3 months
- Active clinical heart failure
- Inability to return for frequent follow up appointments
- Current incarceration
Where it is running
- Cooper University Hospital — Camden, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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