Ascites
Conditions
Keywords
ascites, liver cirrhosis
Brief summary
To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance. Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
Interventions
DEVICENovaShunt's Automated Fluid Shunt implantation
The Automated Fluid Shunt (AFS) Device consists of an implantable sealed housing which contains an internally powered pump with supportive electronic components and circuits, an implantable Peritoneal Catheter, implantable Bladder Catheter and a non-implantable Charger used for wireless recharging an AFS battery and collecting data from the Device.
Sponsors
NovaShunt AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years of age * Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis. * Cirrhosis of any etiology * Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects * Dietary sodium restriction \<88mEq/d. * Serum creatinine levels of ≤ 2.0 mg/dL for at least 7 days before study entry. * Total bilirubin levels of less than 3 mg/dL. * Expected survival of greater than 6 months * Written informed consent * Ability to comply with study procedures and ability to operate the device. * Women of childbearing age should use adequate contraceptives
Exclusion criteria
* Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection. * Presence of peritoneal carcinomatosis * Advanced hepatocellular carcinoma, demonstrated by: 1. One tumor that is \>5 cm diameter 2. 3 or more nodules of \>3 cm diameter 3. Portal thrombosis * Other evidence of a malignant Etiology for Ascites * Evidence of extensive ascites loculation * Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study. * Hepatic encephalopathy in the two weeks prior to implant * Presence of a TIPS or surgical portosystemic shunt * Presence of Budd-Chiari syndrome * Previous liver transplant * Obstructive uropathy * Coagulopathy that could not be corrected to a prothrombin time INR \<1.8, * Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3 * Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator * Any condition requiring emergency treatment * Pregnancy * Patients being in another clinical study that did not reach primary endpoint yet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Paracentesis requirements | 6 month |
| Hematology | 6 month |
| Incidence of hemodynamic instability | 6 month |
| Incidence and severity of peripheral edema | 6 month |
| Patient Quality of Life. | 6 month |
Countries
Belgium, Bulgaria, Germany, Spain
Outcome results
None listed