A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal

Not Applicable

Completed

• Conditions: Refractory Ascites
• Interventions: Device: AFS System

• Registration Number: NCT00870662
• Lead Sponsor: NovaShunt AG

Brief Summary

The purpose of this study is to determine whether the Automatic Fluid Shunt (AFS) can reduce the number of paracentesis procedures in patients with refractory ascites.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-27
• Primary Completion: 2009-12
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-16
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Female or male patients ≥ 18 years of age
• Removal of at least 10 L of ascites in the preceding 2 months for symptom relief
• 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 <90 mcg/d.
• Serum creatinine levels of less than 1.8 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

Exclusion Criteria

• Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
• Presence of peritoneal carcinomatosis
• Evidence of extensive ascites loculation
• 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
• Inability to obtain informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Automatic Fluid Shunt	AFS System	-

Primary Outcome Measures

Name	Time	Method
Number of paracentesis procedures required	6 month

Trial Locations

Locations (2)

IKEM; 🇨🇿 Prague, Czech Republic

Vseobecna fakultni nemocnice v Praze; 🇨🇿 Prague, Czech Republic