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

N

NovaShunt

Status

Completed

Conditions

Refractory Ascites

Treatments

Device: AFS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00870662
2008-AAR-001

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Automatic Fluid Shunt
Experimental group
Treatment:
Device: AFS System

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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