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ALFApump System Versus Standard of Care in Ascites Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528410
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Sequana Medical N.V.

Brief Summary:
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 or disease Intervention/treatment Phase
Refractory or Recurrent Ascites Device: ALFApump removal of ascites Procedure: Large volume paracentesis for removal of ascites Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a single center, open-label trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.
Actual Study Start Date : August 17, 2012
Actual Primary Completion Date : September 21, 2016
Actual Study Completion Date : September 21, 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Paracentesis free survival [ Time Frame: 6 months ]
    Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis > 5 litres

Secondary Outcome Measures :
  1. Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system [ Time Frame: 6 months ]
    Cirrhosis-related complications

  2. Quality of Life [ Time Frame: 6 months ]
  3. Body weight [ Time Frame: 6 months ]
  4. Nutritional profile [ Time Frame: 6 months ]
  5. Resource utilisation [ Time Frame: 6 months ]
  6. Survival [ Time Frame: 6 months ]
  7. Assess the need for repeat evacuation paracentesis [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528410

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Vienna General Hospital and Medical School, AKH
Vienna, Austria
Hopital Beaujon
Clichy, Paris, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Azienda Ospedaliera di Padova
Padova, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Spain
United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Sequana Medical N.V.
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Principal Investigator: Rajiv Jalan, Professor UCL Institute of Hepatology, Royal Free Hospital, London
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sequana Medical N.V. Identifier: NCT01528410    
Other Study ID Numbers: 2012-AAR-005
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Pathologic Processes