Skip to main content
OpenTrials
Completed

NCT Number: NCT01030185

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ascites Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of hepatology, UZ Leuven, campus Gasthuisberg, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovaShunt's Automated Fluid Shunt implantation

Device

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.

Other names: NovaShunt

Primary outcomes

  1. The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events

    Time frame: 6 months

Secondary outcomes

  1. Paracentesis requirements

    Time frame: 6 month

  2. Hematology

    Time frame: 6 month

  3. Incidence of hemodynamic instability

    Time frame: 6 month

  4. Incidence and severity of peripheral edema

    Time frame: 6 month

  5. Patient Quality of Life.

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

NovaShunt AG

Industry

Registry information

Official study 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

Acronym: PIONEER

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Dec 11, 2009
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.