search
Back to results

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

Primary Purpose

Ascites

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NovaShunt's Automated Fluid Shunt implantation
Sponsored by
NovaShunt AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascites focused on measuring ascites, liver cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of hepatology, UZ Leuven, campus Gasthuisberg
  • Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC
  • Military Medical Academy, Clinica of Gastroenterology and Hepatology
  • Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum
  • Medizinische Klinik und Poliklinik I
  • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität
  • Universitätsklinikum Regensburg
  • Hospital General Uneversitario de Alicante
  • Hospital de la Santa Pau I Sant Creu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NovaShunt's Automated Fluid Shunt

Arm Description

The Automated Fluid Shunt (AFS) Device

Outcomes

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

Secondary Outcome Measures

Paracentesis requirements
Hematology
Incidence of hemodynamic instability
Incidence and severity of peripheral edema
Patient Quality of Life.

Full Information

First Posted
December 10, 2009
Last Updated
September 5, 2013
Sponsor
NovaShunt AG
search

1. Study Identification

Unique Protocol Identification Number
NCT01030185
Brief Title
Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
Acronym
PIONEER
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovaShunt AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites
Keywords
ascites, liver cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NovaShunt's Automated Fluid Shunt
Arm Type
Experimental
Arm Description
The Automated Fluid Shunt (AFS) Device
Intervention Type
Device
Intervention Name(s)
NovaShunt's Automated Fluid Shunt implantation
Other Intervention Name(s)
NovaShunt
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Paracentesis requirements
Time Frame
6 month
Title
Hematology
Time Frame
6 month
Title
Incidence of hemodynamic instability
Time Frame
6 month
Title
Incidence and severity of peripheral edema
Time Frame
6 month
Title
Patient Quality of Life.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Such, MD
Organizational Affiliation
Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of hepatology, UZ Leuven, campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC
City
Sofia
ZIP/Postal Code
1404
Country
Bulgaria
Facility Name
Military Medical Academy, Clinica of Gastroenterology and Hepatology
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Hospital General Uneversitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital de la Santa Pau I Sant Creu
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs