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

N

NovaShunt AG

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: 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

NovaShunt's Automated Fluid Shunt
Experimental group
Description:
The Automated Fluid Shunt (AFS) Device
Treatment:
Device: NovaShunt's Automated Fluid Shunt implantation

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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