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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sequana Medical AG
Sponsor:
Information provided by (Responsible Party):
Sequana Medical AG
ClinicalTrials.gov Identifier:
NCT01952327
First received: September 24, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Pleural Effusion
Device: The pleurapump system

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.

Resource links provided by NLM:


Further study details as provided by Sequana Medical AG:

Primary Outcome Measures:
  • Incidence and severity of device, procedure and therapy related serious adverse events. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Subjective thoracic pain on the side of the intervention (measured using VAS score)

  • Subjective abdominal pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Subjective abdominal pain (measured using VAS score)

  • Subjective breathlessness [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Subjective breathlessness (measured using VAS score)

  • Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Quality of life, measured using EQ-5D health questionnaires

  • Costs of health resource use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Costs of health resource use over the study period


Estimated Enrollment: 8
Study Start Date: May 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
plueurapump
Implantation of pleurapump system
Device: The pleurapump system
Implantation of the pleurapump system
Other Name: The pleurapump system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952327

Locations
France
Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord Recruiting
Marseille, France, 13326
Contact: Philippe Astoul, Professor       PhilippeJean.ASTOUL@ap-hm.fr   
Principal Investigator: Philippe Astoul, Professor         
United Kingdom
Dept. of Respiratory Medicine, Southmead Hospital Not yet recruiting
Bristol, United Kingdom, BS10 5NB
Contact: Nick Maskell, MD         
Principal Investigator: Nick Maskell, MD         
Sponsors and Collaborators
Sequana Medical AG
Investigators
Principal Investigator: Nick Maskell, MD Dept. of Respiratory Medicine, Southmead Hospital, Bristol, BS10 5NB, United Kingdom
  More Information

No publications provided

Responsible Party: Sequana Medical AG
ClinicalTrials.gov Identifier: NCT01952327     History of Changes
Other Study ID Numbers: 2013-AAR-008
Study First Received: September 24, 2013
Last Updated: June 18, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014