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Clinical Trials/NCT01030185
NCT01030185CompletedPhase 2

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

NovaShunt AG18 sites in 4 countries40 target enrollmentStarted: February 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
40
Locations
18
Primary Endpoint
The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor
NovaShunt AG
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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