Back to resultsInvestigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy. (ADEPT)
Primary Purpose
Pleural Effusion
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The pleurapump system
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Effusion
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
Sites / Locations
- Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord
- Dept. of Respiratory Medicine, Southmead Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
plueurapump
Arm Description
Implantation of pleurapump system
Outcomes
Primary Outcome Measures
Incidence and severity of device, procedure and therapy related serious adverse events.
Incidence and severity of device, procedure and therapy related serious adverse events.
Secondary Outcome Measures
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
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.
Subjective thoracic pain on the side of the intervention
Subjective thoracic pain on the side of the intervention (measured using VAS score)
Subjective abdominal pain
Subjective abdominal pain (measured using VAS score)
Subjective breathlessness
Subjective breathlessness (measured using VAS score)
Quality of life
Quality of life, measured using EQ-5D health questionnaires
Costs of health resource use
Costs of health resource use over the study period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01952327
Brief Title
Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
Acronym
ADEPT
Official Title
Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 13, 2016 (Actual)
Study Completion Date
December 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sequana Medical N.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
plueurapump
Arm Type
Other
Arm Description
Implantation of pleurapump system
Intervention Type
Device
Intervention Name(s)
The pleurapump system
Intervention Description
Implantation of the pleurapump system
Primary Outcome Measure Information:
Title
Incidence and severity of device, procedure and therapy related serious adverse events.
Description
Incidence and severity of device, procedure and therapy related serious adverse events.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy of treatment as assessed by the volume of fluid removed
Description
Efficacy of treatment as assessed by the volume of fluid removed by the pump
Time Frame
3 months
Title
Need for further intervention to manage pleural fluid (on the side of the intervention)
Description
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.
Time Frame
3 months
Title
Subjective thoracic pain on the side of the intervention
Description
Subjective thoracic pain on the side of the intervention (measured using VAS score)
Time Frame
3 months
Title
Subjective abdominal pain
Description
Subjective abdominal pain (measured using VAS score)
Time Frame
3 months
Title
Subjective breathlessness
Description
Subjective breathlessness (measured using VAS score)
Time Frame
3 months
Title
Quality of life
Description
Quality of life, measured using EQ-5D health questionnaires
Time Frame
3 months
Title
Costs of health resource use
Description
Costs of health resource use over the study period
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Maskell, MD
Organizational Affiliation
Dept. of Respiratory Medicine, Southmead Hospital, Bristol, BS10 5NB, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord
City
Marseille
ZIP/Postal Code
13326
Country
France
Facility Name
Dept. of Respiratory Medicine, Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
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