Ascites, Cirrhosis
Conditions
Brief summary
The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.
Interventions
DEVICEalfapump system
The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.
Sponsors
Sequana Medical N.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients ≥ 21 years of age 2. recurrence of grade 3 ascites requiring paracentesis for symptom relief more frequently than once per month for a minimum of 2 of the prior 3 months 3. cirrhosis of any etiology 4. failure to respond to or intolerance to high dose diuretics 5. expected survival of greater than 3 months (MELD score ≤ 21) 6. screened for varices and on optimal management 7. diagnostic paracentesis with neutrophil count \< 250 / µl within 24 hours of implantation 8. written informed consent 9. ability to comply with study procedures and ability to operate the device 10. women of childbearing potential should use adequate contraception
Exclusion criteria
1. more than 2 systemic or local infections, such as peritonitis, urinary tract infection, or abdominal skin infection within the last 6 months 2. presence of any current cancer 3. evidence of extensive ascites loculation 4. serum creatinine \> 1.5 mg/dl 5. serum bilirubin \> 5 mg/dl 6. eGFR \< 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method 7. gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to inclusion in the study 8. hepatic encephalopathy \> stage II in the two weeks prior to implant 9. presence of a patent TIPS or surgical portosystemic shunt 10. presence of Budd-Chiari syndrome 11. previous solid organ transplant 12. obstructive uropathy (bladder residual volume \> 100ml (determined by catheterization or abdominal ultrasound) or any bladder anomaly which may contraindicate implantation of the alfapump, including recurrent urinary tract infections, vesicoureteral reflux, or history of urinary calculi) 13. International Prostate Symptom Score (I-PSS) ≥20 14. thrombocytopenia \< 45,000 X106/l 15. patient undergoing therapeutic anticoagulation 16. recent (\<4 months) intra-abdominal foreign body or abdominal surgery, diaphragmatic hernia, abdominal surgery, severe abdominal adhesions, surgically irreparable hernia, abdominal wall or skin infection, or severe malnutrition. 17. history (\>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory or ischemic bowel disease, and frequent episodes of diverticulitis. 18. any non-liver disease with life expectancy \< 1 year 19. patients eligible for TIPS (unless they have refused TIPS placement). 20. presence of any active implantable or body-worn devices that cannot be removed 21. pregnancy 22. patients being in another therapeutic clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of serious adverse events related to the device and its implantation. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the overall requirement for large volume paracentesis | 12 months | Assess the overall requirement for large volume paracentesis by investigation of: * the number of large volume therapeutic paracentesis events and all paracentesis events * the annualized rate of large volume therapeutic paracentesis and of all paracentesis events * the cumulative volume of ascites removed through all paracentesis events • Assess the overall requirement for large volume paracentesis by investigation of: * the number of large volume therapeutic paracentesis events and all paracentesis events * the annualized rate of large volume therapeutic paracentesis and of all paracentesis events * the cumulative volume of ascites removed through all paracentesis events |
| Nutritional status | 12 months | Nutritional status o evaluate changes in serum prealbumin |
| Evaluate patient quality of life | 12 months | Evaluate patient quality of life * chronic liver disease questionnaire (CLDQ) * PLD questionnaire * ECOG performance status |
| Overall survival | 12 months | — |
Countries
Canada, United States
Outcome results
None listed