ALFApump System Versus Standard of Care in Ascites Treatment

Sequana Medical

Status and phase

Completed

Phase 3

Conditions

Refractory or Recurrent Ascites

Treatments

Procedure: Large volume paracentesis for removal of ascites

Device: ALFApump removal of ascites

Study type

Interventional

Funder types

Industry

Identifiers

NCT01528410

2012-AAR-005

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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