Clinical trial NCT01952327: Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
Official title: Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pleural Effusion
Lead sponsor: Sequana Medical N.V.
Sponsor class: INDUSTRY
First posted: 2013-09-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a research study examining the safety of a new, automated pump for the drainage of fluid in the chest cavity which is caused by cancer (also known as malignant pleural effusion, or MPE). The purpose of the trial is to assess whether the new pleurapump device is safe and effective in the management of patients with MPE. The study will try to identify what kind of problems may arise from using the device, how often they happen, and how severe they are if they occur.


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

Primary outcomes:
measure: Incidence and severity of device, procedure and therapy related serious adverse events.
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy of treatment as assessed by the volume of fluid removed
timeFrame: 3 months
measure: Need for further intervention to manage pleural fluid (on the side of the intervention)
timeFrame: 3 months
measure: Subjective thoracic pain on the side of the intervention
timeFrame: 3 months
measure: Subjective abdominal pain
timeFrame: 3 months
measure: Subjective breathlessness
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Costs of health resource use
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord
city: Bristol
country: United Kingdom
facility: Dept. of Respiratory Medicine, Southmead Hospital
Study officials:
affiliation: Dept. of Respiratory Medicine, Southmead Hospital, Bristol, BS10 5NB, United Kingdom
name: Nick Maskell, MD
role: PRINCIPAL_INVESTIGATOR
References: