A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
NCT ID: NCT00870662
Last Updated: 2011-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Automatic Fluid Shunt
AFS System
AFS System with patient specific flow rate
Interventions
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AFS System
AFS System with patient specific flow rate
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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NovaShunt AG
INDUSTRY
Responsible Party
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Locations
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Vseobecna fakultni nemocnice v Praze
Prague, Prague, Czechia
IKEM
Prague, , Czechia
Countries
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Other Identifiers
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2008-AAR-001
Identifier Type: -
Identifier Source: org_study_id