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

NCT ID: NCT01030185

Last Updated: 2013-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-06-30

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.

Conditions

Ascites

Keywords

ascites; liver cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NovaShunt's Automated Fluid Shunt

The Automated Fluid Shunt (AFS) Device

Group Type: EXPERIMENTAL

NovaShunt's Automated Fluid Shunt implantation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

NovaShunt

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovaShunt AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Such, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain

Locations

Department of hepatology, UZ Leuven, campus Gasthuisberg

Leuven, , Belgium

Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC

Sofia, , Bulgaria

Military Medical Academy, Clinica of Gastroenterology and Hepatology

Sofia, , Bulgaria

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, , Germany

Hospital General Uneversitario de Alicante

Alicante, , Spain

Hospital de la Santa Pau I Sant Creu

Barcelona, , Spain

Countries

Belgium; Bulgaria; Germany; Spain

Other Identifiers

2009-AAR-002

Identifier Type: -

Identifier Source: org_study_id