Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.

Not Applicable

Terminated

• Conditions: Pleural Effusion
• Interventions: Device: The pleurapump system

• Registration Number: NCT01952327
• Lead Sponsor: Sequana Medical N.V.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Study Start: 2014-05
• Primary Completion: 2016-12-13
• Study Completion: 2016-12-13
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
plueurapump	The pleurapump system	Implantation of pleurapump system

Primary Outcome Measures

Name	Time	Method
Incidence and severity of device, procedure and therapy related serious adverse events.	3 months	Incidence and severity of device, procedure and therapy related serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Efficacy of treatment as assessed by the volume of fluid removed	3 months	Efficacy of treatment as assessed by the volume of fluid removed by the pump
Subjective thoracic pain on the side of the intervention	3 months	Subjective thoracic pain on the side of the intervention (measured using VAS score)
Costs of health resource use	3 months	Costs of health resource use over the study period
Quality of life	3 months	Quality of life, measured using EQ-5D health questionnaires
Need for further intervention to manage pleural fluid (on the side of the intervention)	3 months	Need for further intervention to manage pleural fluid (on the side of the intervention), including therapeutic thoracentesis of greater than 100mls, insertion of an indwelling catheter, insertion of an intercostal drain for fluid management, or thoracoscopy.
Subjective abdominal pain	3 months	Subjective abdominal pain (measured using VAS score)
Subjective breathlessness	3 months	Subjective breathlessness (measured using VAS score)

Trial Locations

Locations (2)

Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord; 🇫🇷 Marseille, France

Dept. of Respiratory Medicine, Southmead Hospital; 🇬🇧 Bristol, United Kingdom