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| ID | Type | Description | Link |
|---|---|---|---|
| CI20130054 | Other Identifier | UK MHRA |
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The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Indwelling Pleural Catheter | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Indwelling Pleural Catheter | Device | Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device -related safety and the number of adverse events. | 28 days post catheter insertion |
| Measure | Description | Time Frame |
|---|---|---|
| pleurodesis success | Assessed by chest x-ray, thorachic ultrasound, and confirmation the catheter is patent. | 14 days |
| Pleurodesis success | Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent. |
| Measure | Description | Time Frame |
|---|---|---|
| Breathlesness | 14, 28, 60 days | |
| Chest Pain | 14, 28, 60 days | |
| Time to pleurodesis |
Inclusion Criteria:
Subject is ≥ 18 years old.
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:
Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.
Subject is willing and able to provide written informed consent.
Subject is willing and able to meet all study requirements, including attending follow-up visits or receiving trial-related telephone calls.
There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
Negative pregnancy test if appropriate
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southmead Hospital - Academic Resporatory Unit | Westbury on Severn | Bristol | BS10 5NB | United Kingdom |
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| 28 days |
| pleurodesis success | Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent. | 60 days |
| 14, 28, 60 days |
| Quality of Life | 14, 28, 60 days |
| Need for further pleural intervention post catheter removal | 60 days |
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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