Clinical trial NCT01030185: Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ascites
Keywords: ascites
liver cirrhosis
Lead sponsor: NovaShunt AG
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Paracentesis requirements
timeFrame: 6 month
measure: Hematology
timeFrame: 6 month
measure: Incidence of hemodynamic instability
timeFrame: 6 month
measure: Incidence and severity of peripheral edema
timeFrame: 6 month
measure: Patient Quality of Life.
timeFrame: 6 month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of hepatology, UZ Leuven, campus Gasthuisberg
city: Sofia
country: Bulgaria
facility: Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC
city: Sofia
country: Bulgaria
facility: Military Medical Academy, Clinica of Gastroenterology and Hepatology
city: Berlin
country: Germany
facility: Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum
city: Bonn
country: Germany
facility: Medizinische Klinik und Poliklinik I
city: Frankfurt
country: Germany
facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Alicante
country: Spain
facility: Hospital General Uneversitario de Alicante
city: Barcelona
country: Spain
facility: Hospital de la Santa Pau I Sant Creu
Study officials:
affiliation: Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain
name: Jose Such, MD
role: PRINCIPAL_INVESTIGATOR
References: