ALFApump System Versus Standard of Care in Ascites Treatment

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:
NCT01528410
First received: January 31, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.


Condition Intervention Phase
Refractory or Recurrent Ascites
Device: ALFApump removal of ascites
Procedure: Large volume paracentesis for removal of ascites
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.

Further study details as provided by Sequana Medical AG:

Primary Outcome Measures:
  • Paracentesis free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis > 5 litres


Secondary Outcome Measures:
  • Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Cirrhosis-related complications

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nutritional profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Resource utilisation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Assess the need for repeat evacuation paracentesis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALFApump removal of ascites
Removal of ascites
Device: ALFApump removal of ascites
Implanted ALFApump, removing produced ascites according to programmed schedule
Other Name: ALFApump (Automated Low Flow Ascites pump)
Active Comparator: Large volume paracentesis for removal of ascites
Removal of ascites
Procedure: Large volume paracentesis for removal of ascites
Large volume paracentesis - standard of care, removing ascites according to patient need
Other Name: Extraction of fluid from the abdominal cavity

  Eligibility

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

Inclusion Criteria:

  1. Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤ 1% failure rate) method of contraception during the course of the study
  2. Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria
  3. Presenting refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin).
  4. Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device

Exclusion Criteria:

  1. Gastrointestinal haemorrhage over the last 7 days
  2. Renal failure defined as serum creatinine higher than or equal to 2 mg/dl
  3. Severe coagulopathy defined as prothrombin time greater than 40% more than upper limit of Normal (as determined locally).
  4. Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
  5. Clinical Evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
  6. Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
  7. Clinical evidence of loculated ascites.
  8. Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
  9. Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
  10. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to, cardiac pacemaker or cardioverter defibrillator.
  11. Pregnant females or females anticipating pregnancy during study period
  12. Patients currently enrolled in another interventional clinical study
  13. Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)
  14. Known presence of human immunodeficiency virus (HIV)
  15. Immuno-modulatory treatment (including azothioprine, methotrexate, anti-TNF therapies) used within last 4 months
  16. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years
  17. BMI > 40 presenting a risk for surgery and tunneled lines
  18. Patients with contraindications for general anesthesia
  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: NCT01528410

Contacts
Contact: Rajiv Jalan, Professor +44 207 433 2795 r.jalan@ucl.ac.uk

Locations
Austria
Vienna General Hospital and Medical School, AKH Recruiting
Vienna, Austria
Contact: Markus Peck-Radosavljevic, Professor       markus.peck@meduniwien.ac.at   
Principal Investigator: Markus Peck-Radosavljevic, Professor         
France
Hopital Beaujon Recruiting
Clichy, Paris, France
Contact: Laure Elkrief, MD       laure.elkrief@bjn.aphp.fr   
Principal Investigator: Laure Elkrief, MD         
Centre Hospitalier Universitaire de Toulouse Recruiting
Toulouse, France
Contact: Christoph Bureau, Professor       bureau.c@chu-toulouse.fr   
Principal Investigator: Christoph Bureau, Professor         
Italy
Azienda Ospedaliera di Padova Recruiting
Padova, Italy
Contact: Paolo Angeli, MD       pangeli@unipd.it   
Principal Investigator: Paolo Angeli, Professor         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Victor Vargas Blasco, MD         
Principal Investigator: Victor Vargas Blasco, MD         
United Kingdom
Bristol Royal Infirmary Recruiting
Bristol, United Kingdom
Contact: Anne McCune, MD       anne.mccune@uhbristol.nhs.uk   
Principal Investigator: Anne McCune, MD         
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Rajiv Jalan, Professor       r.jalan@ucl.ac.uk   
Principal Investigator: Rajiv Jalan, Professor         
Sponsors and Collaborators
Sequana Medical AG
Investigators
Principal Investigator: Rajiv Jalan, Professor UCL Institute of Hepatology, Royal Free Hospital, London
  More Information

No publications provided

Responsible Party: Sequana Medical AG
ClinicalTrials.gov Identifier: NCT01528410     History of Changes
Other Study ID Numbers: 2012-AAR-005
Study First Received: January 31, 2012
Last Updated: June 18, 2014
Health Authority: United Kingdom: National Health Service
Austria: Austrian Medicines and Medical Devices Agency
Austria: Ethikkommission
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Institutional Ethical Committee
Italy: Ethics Committee
Spain: Ethics Committee

Additional relevant MeSH terms:
Ascites
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014