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

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.

Study Overview

• Status: Terminated
• Conditions: Pleural Effusion
• Intervention / Treatment: Device: The pleurapump system

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13326
    • Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Dept. of Respiratory Medicine, Southmead Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: plueurapump; Implantation of pleurapump system	Device: The pleurapump system; Implantation of the pleurapump system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of device, procedure and therapy related serious adverse events.	Incidence and severity of device, procedure and therapy related serious adverse events.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of treatment as assessed by the volume of fluid removed	Efficacy of treatment as assessed by the volume of fluid removed by the pump	3 months
Need for further intervention to manage pleural fluid (on the side of the intervention)	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.	3 months
Subjective thoracic pain on the side of the intervention	Subjective thoracic pain on the side of the intervention (measured using VAS score)	3 months
Subjective abdominal pain	Subjective abdominal pain (measured using VAS score)	3 months
Subjective breathlessness	Subjective breathlessness (measured using VAS score)	3 months
Quality of life	Quality of life, measured using EQ-5D health questionnaires	3 months
Costs of health resource use	Costs of health resource use over the study period	3 months

Collaborators and Investigators

• Sponsor: Sequana Medical N.V.
• Investigators: Principal Investigator: Nick Maskell, MD, Dept. of Respiratory Medicine, Southmead Hospital, Bristol, BS10 5NB, United Kingdom

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 13, 2016
• Study Completion (Actual): December 13, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 2013-AAR-008