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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovaShunt AG
ClinicalTrials.gov Identifier:
NCT01030185
First received: December 10, 2009
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Ascites
Device: NovaShunt's Automated Fluid Shunt implantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NovaShunt AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Paracentesis requirements [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Hematology [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Incidence of hemodynamic instability [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Incidence and severity of peripheral edema [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Patient Quality of Life. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NovaShunt's Automated Fluid Shunt
The Automated Fluid Shunt (AFS) Device
Device: NovaShunt's Automated Fluid Shunt implantation
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 Name: NovaShunt

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030185

Locations
Belgium
Department of hepatology, UZ Leuven, campus Gasthuisberg
Leuven, Belgium, 3000
Bulgaria
Military Medical Academy, Clinica of Gastroenterology and Hepatology
Sofia, Bulgaria, 1606
Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC
Sofia, Bulgaria, 1404
Germany
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum
Berlin, Germany, 13353
Medizinische Klinik und Poliklinik I
Bonn, Germany, 53105
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität
Frankfurt, Germany, 60590
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Spain
Hospital General Uneversitario de Alicante
Alicante, Spain, 03010
Hospital de la Santa Pau I Sant Creu
Barcelona, Spain, 08025
Sponsors and Collaborators
NovaShunt AG
Investigators
Principal Investigator: Jose Such, MD Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain
  More Information

No publications provided

Responsible Party: NovaShunt AG
ClinicalTrials.gov Identifier: NCT01030185     History of Changes
Other Study ID Numbers: 2009-AAR-002
Study First Received: December 10, 2009
Last Updated: September 5, 2013
Health Authority: Spain: Ethics Committee
Germany: Ethics Commission

Keywords provided by NovaShunt AG:
ascites
liver cirrhosis

Additional relevant MeSH terms:
Ascites
Pathologic Processes
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014