Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
- Conditions
- Ascites
- Interventions
- Device: NovaShunt's Automated Fluid Shunt implantation
- Registration Number
- NCT01030185
- Lead Sponsor
- NovaShunt AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NovaShunt's Automated Fluid Shunt NovaShunt's Automated Fluid Shunt implantation The Automated Fluid Shunt (AFS) Device
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (9)
Department of hepatology, UZ Leuven, campus Gasthuisberg
🇧🇪Leuven, Belgium
Military Medical Academy, Clinica of Gastroenterology and Hepatology
🇧🇬Sofia, Bulgaria
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum
🇩🇪Berlin, Germany
Medizinische Klinik und Poliklinik I
🇩🇪Bonn, Germany
Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC
🇧🇬Sofia, Bulgaria
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität
🇩🇪Frankfurt, Germany
Hospital General Uneversitario de Alicante
🇪🇸Alicante, Spain
Hospital de la Santa Pau I Sant Creu
🇪🇸Barcelona, Spain