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

NCT ID: NCT01952327

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-12-13

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.

Conditions

Pleural Effusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

plueurapump

Implantation of pleurapump system

Group Type: OTHER

The pleurapump system

Intervention Type: DEVICE

Implantation of the pleurapump system

Interventions

The pleurapump system

Implantation of the pleurapump system

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sequana Medical N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Maskell, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Respiratory Medicine, Southmead Hospital, Bristol, BS10 5NB, United Kingdom

Locations

Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord

Marseille, , France

Dept. of Respiratory Medicine, Southmead Hospital

Bristol, , United Kingdom

Countries

France; United Kingdom

Other Identifiers

2013-AAR-008

Identifier Type: -

Identifier Source: org_study_id