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

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ClinicalTrials.gov Identifier: NCT00870662
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : December 19, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Refractory Ascites Device: AFS System

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
Study Start Date : December 2008
Primary Completion Date : December 2009

Arm Intervention/treatment
Experimental: Automatic Fluid Shunt Device: AFS System
AFS System with patient specific flow rate

Primary Outcome Measures :
  1. Number of paracentesis procedures required [ Time Frame: 6 month ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870662

Czech Republic
Vseobecna fakultni nemocnice v Praze
Prague, Czech Republic, 128 08
Prague, Czech Republic
Sponsors and Collaborators
NovaShunt AG

Responsible Party: NovaShunt AG
ClinicalTrials.gov Identifier: NCT00870662     History of Changes
Other Study ID Numbers: 2008-AAR-001
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Pathologic Processes