Pleural EffusionADEPTNCT01952327
Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
A study testing The pleurapump system in people with Pleural Effusion, run by Sequana Medical N.V. at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- The pleurapump system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2014to 13 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord
Marseille, 13326
United Kingdom1 site
Dept. of Respiratory Medicine, Southmead Hospital
Bristol, BS10 5NB
About this study
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
- Being tested
- The pleurapump system
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The pleurapump systemDevice
Implantation of the pleurapump system
| Study group | Role | What they receive |
|---|---|---|
| plueurapump | Other | Implantation of pleurapump system Receives: Device: The pleurapump system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of device, procedure and therapy related serious adverse events.
Incidence and severity of device, procedure and therapy related serious adverse events.
Measured: 3 months
Secondary outcomes (7)
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
Measured: 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.
Measured: 3 months
Subjective thoracic pain on the side of the intervention
Subjective thoracic pain on the side of the intervention (measured using VAS score)
Measured: 3 months
Subjective abdominal pain
Subjective abdominal pain (measured using VAS score)
Measured: 3 months
Subjective breathlessness
Subjective breathlessness (measured using VAS score)
Measured: 3 months
Quality of life
Quality of life, measured using EQ-5D health questionnaires
Measured: 3 months
Costs of health resource use
Costs of health resource use over the study period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startMay 2014
- Primary completion13 Dec 2016
- Study completion13 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nick Maskell, MD, Principal investigator, Dept. of Respiratory Medicine, Southmead Hospital, Bristol, BS10 5NB, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952327
- Sponsor's protocol ID
- 2013-AAR-008
- Acronym
- ADEPT
- Status last verified
- Jun 2017
- First submitted
- 24 Sep 2013
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
- ClinicalTrials.gov ID
- NCT01952327
- Acronym / sponsor ID
- ADEPT / 2013-AAR-008
- Conditions
- Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 13 Dec 2016 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| plueurapump | Other | Device: The pleurapump systemImplantation of pleurapump system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The pleurapump systemImplantation of the pleurapump system | Device | plueurapump |
Primary outcome
Incidence and severity of device, procedure and therapy related serious adverse events.
Time frame: 3 months
Incidence and severity of device, procedure and therapy related serious adverse events.
7 secondary outcomes
Efficacy of treatment as assessed by the volume of fluid removed
Time frame: 3 months
Need for further intervention to manage pleural fluid (on the side of the intervention)
Time frame: 3 months
Subjective thoracic pain on the side of the intervention
Time frame: 3 months
Subjective abdominal pain
Time frame: 3 months
Subjective breathlessness
Time frame: 3 months
Quality of life
Time frame: 3 months
Costs of health resource use
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Maskell, MD principal investigator
Dept. of Respiratory Medicine, Southmead Hospital, Bristol, BS10 5NB, United Kingdom
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The pleurapump system in people with Pleural Effusion, run by Sequana Medical N.V. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of device, procedure and therapy related serious adverse events. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.