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

Refractory Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870662
• Other study ID #: 2008-AAR-001
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: December 16, 2011
• Start date: December 2008

Study information

• Verified date: December 2011
• Source: NovaShunt AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Refractory Ascites

Intervention

Device:
• AFS System
AFS System with patient specific flow rate

Locations

Country	Name	City	State
Czech Republic	IKEM	Prague
Czech Republic	Vseobecna fakultni nemocnice v Praze	Prague

Sponsors (1)

Lead Sponsor	Collaborator
NovaShunt AG

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of paracentesis procedures required		6 month	No