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

NCT01030185 | Completed Phase 2 DMC

• 1 other identifier: 2009-AAR-002
• Study Type: interventional
• Target: 40
• Locations: 4 countries
• Sites: 9

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

Outcome Measures

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

  6 months

Secondary Outcomes (5)

• Paracentesis requirements

  6 month

• Hematology

  6 month

• Incidence of hemodynamic instability

  6 month

• Incidence and severity of peripheral edema

  6 month

• Patient Quality of Life.

  6 month

Study Arms (1)

NovaShunt's Automated Fluid Shunt

EXPERIMENTAL

The Automated Fluid Shunt (AFS) Device

Device: NovaShunt's Automated Fluid Shunt implantation

Interventions

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.

Also known as: NovaShunt

NovaShunt's Automated Fluid Shunt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• or more nodules of \>3 cm diameter
• Portal thrombosis
• Other evidence of a malignant Etiology for Ascites
• Evidence of extensive ascites loculation
• 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

Sponsors & Collaborators

• NovaShunt AG: lead

Study Sites (9)

Department of hepatology, UZ Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Location

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

Sofia, 1404, Bulgaria

Location

Military Medical Academy, Clinica of Gastroenterology and Hepatology

Sofia, 1606, Bulgaria

Location

Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Medizinische Klinik und Poliklinik I

Bonn, 53105, Germany

Location

Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität

Frankfurt, 60590, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Hospital General Uneversitario de Alicante

Alicante, 03010, Spain

Location

Hospital de la Santa Pau I Sant Creu

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Ascites; Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose Such, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

DE (4); ES (2); BE (1); BU (2)