Refractory or Recurrent Ascites
Conditions
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.
Interventions
DEVICEALFApump removal of ascites
Implanted ALFApump, removing produced ascites according to programmed schedule
PROCEDURELarge volume paracentesis for removal of ascites
Large volume paracentesis - standard of care, removing ascites according to patient need
Sponsors
Sequana Medical N.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be a single center, open-label trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paracentesis free survival | 6 months | Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis \> 5 litres |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 6 months | — |
| Body weight | 6 months | — |
| Nutritional profile | 6 months | — |
| Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system | 6 months | Cirrhosis-related complications |
| Survival | 6 months | — |
| Assess the need for repeat evacuation paracentesis | 6 months | — |
| Resource utilisation | 6 months | — |
Countries
Austria, France, Italy, Spain, United Kingdom
Outcome results
None listed