Status:
COMPLETED
A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
Lead Sponsor:
NovaShunt AG
Conditions:
Refractory Ascites
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00870662
Start Date
December 1 2008
Last Update
December 19 2011
Active Locations (2)
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1
Vseobecna fakultni nemocnice v Praze
Prague, Prague, Czechia, 128 08
2
IKEM
Prague, Czechia