NCT01952327

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2016

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2.6 years

First QC Date

September 24, 2013

Last Update Submit

June 12, 2017

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Efficacy of treatment as assessed by the volume of fluid removed

    3 months

  • Need for further intervention to manage pleural fluid (on the side of the intervention)

    3 months

  • Subjective thoracic pain on the side of the intervention

    3 months

  • Subjective abdominal pain

    3 months

  • Subjective breathlessness

    3 months

  • +2 more secondary outcomes

Study Arms (1)

plueurapump

OTHER

Implantation of pleurapump system

Device: The pleurapump system

Interventions

The pleurapump systemDEVICE

Implantation of the pleurapump system

plueurapump

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years of age
  • 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.
  • or more therapeutic procedures for pleural fluid drainage prior to enrolment.
  • Written informed consent
  • Ability to comply with study procedures and ability to operate the device
  • Expected survival of more than 3 months after device insertion

You may not qualify if:

  • Haemothorax
  • Purulent pleural effusion
  • Significant pleural fluid septation or loculation on thoracic ultrasound or cross-sectional imaging
  • Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
  • Pregnant females or females anticipating pregnancy during study period.
  • Patients currently enrolled in another interventional clinical study
  • Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardioverter defibrillator.
  • 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.)
  • Other contraindication to general anaesthesia
  • Other contraindication to procedure (e.g. uncorrectable bleeding diathesis, infection or malignant involvement over proposed insertion site)
  • Significant renal impairment, as determined by the principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Marseille, 13326, France

Location

Dept. of Respiratory Medicine, Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Nick Maskell, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2013

First Posted

September 27, 2013

Study Start

May 1, 2014

Primary Completion

December 13, 2016

Study Completion

December 13, 2016

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

FR(1)GB(1)