Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-center, Open Label, Non-randomized Study to Investigate the Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance

Conditions
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Ascites

Intervention / Treatment
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* Device: NovaShunt's Automated Fluid Shunt implantation


Participation Criteria
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Eligibility Criteria
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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: One tumor that is >5 cm diameter 3 or more nodules of >3 cm diameter 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NovaShunt's Automated Fluid Shunt<br>The Automated Fluid Shunt (AFS) Device | Device: NovaShunt's Automated Fluid Shunt implantation<br>* 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.<br>* Other names: NovaShunt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ascites, liver cirrhosis