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

Ascites Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030185
• Other study ID #: 2009-AAR-002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 10, 2009
• Last updated: September 5, 2013
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: NovaShunt AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ascites

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NovaShunt AG

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events		6 months	Yes
Secondary	Paracentesis requirements		6 month	Yes
Secondary	Hematology		6 month	No
Secondary	Incidence of hemodynamic instability		6 month	No
Secondary	Incidence and severity of peripheral edema		6 month	No
Secondary	Patient Quality of Life.		6 month	No