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

NovaShunt

Status and phase

Completed

Phase 3

Phase 2

Conditions

Ascites

Treatments

Device: NovaShunt's Automated Fluid Shunt implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01030185

2009-AAR-002

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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