Investigation Into the Automated Drainage of Recurrent Ef... | NCT01952327

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

NCT01952327

Sponsor

Sequana Medical N.V.

Status

Terminated

Last Update Posted

Jun 14, 2017Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Pleural Effusion

Interventions

The pleurapump system

Countries

France
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 13, 2016Actual

Completion Date

Dec 13, 2016Actual

First Submitted Date

Sep 24, 2013

First Submission Date that Met QC Criteria

Sep 24, 2013

First Posted Date

Sep 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2017

Last Update Posted Date

Jun 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
plueurapump	Other	Implantation of pleurapump system	Device: The pleurapump system

Name	Type	Description	Arm Group Labels	Other Names
The pleurapump system	Device	Implantation of the pleurapump system	plueurapump

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 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.
1 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases