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

Pleural Effusion Clinical Trial

— ADEPT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01952327
• Other study ID #: 2013-AAR-008
• Status: Terminated
• Phase: N/A
• First received: September 24, 2013
• Last updated: June 12, 2017
• Start date: May 2014
• Est. completion date: December 13, 2016

Study information

• Verified date: June 2017
• Source: Sequana Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 13, 2016
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• The pleurapump system
Implantation of the pleurapump system

Locations

Country	Name	City	State
France	Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord	Marseille
United Kingdom	Dept. of Respiratory Medicine, Southmead Hospital	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
Sequana Medical AG

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Subjective thoracic pain on the side of the intervention	Subjective thoracic pain on the side of the intervention (measured using VAS score)	3 months
Secondary	Subjective abdominal pain	Subjective abdominal pain (measured using VAS score)	3 months
Secondary	Subjective breathlessness	Subjective breathlessness (measured using VAS score)	3 months
Secondary	Quality of life	Quality of life, measured using EQ-5D health questionnaires	3 months
Secondary	Costs of health resource use	Costs of health resource use over the study period	3 months