Status:
COMPLETED
ALFApump System Versus Standard of Care in Ascites Treatment
Lead Sponsor:
Sequana Medical N.V.
Conditions:
Refractory or Recurrent Ascites
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria
- 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).
- Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device
Exclusion
- Gastrointestinal haemorrhage over the last 7 days
- Renal failure defined as serum creatinine higher than or equal to 2 mg/dl
- Severe coagulopathy defined as prothrombin time greater than 40% more than upper limit of Normal (as determined locally).
- Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
- 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.
- 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.
- Clinical evidence of loculated ascites.
- Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
- Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
- Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to, cardiac pacemaker or cardioverter defibrillator.
- Pregnant females or females anticipating pregnancy during study period
- Patients currently enrolled in another interventional clinical study
- Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)
- Known presence of human immunodeficiency virus (HIV)
- Immuno-modulatory treatment (including azothioprine, methotrexate, anti-TNF therapies) used within last 4 months
- Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years
- BMI \> 40 presenting a risk for surgery and tunneled lines
- Patients with contraindications for general anesthesia
Key Trial Info
Start Date :
August 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01528410
Start Date
August 17 2012
End Date
September 21 2016
Last Update
June 14 2017
Active Locations (7)
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1
Vienna General Hospital and Medical School, AKH
Vienna, Austria
2
Hopital Beaujon
Clichy, Paris, France
3
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
4
Azienda Ospedaliera di Padova
Padua, Italy