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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovaShunt AG
ClinicalTrials.gov Identifier:
NCT00870662
First received: March 25, 2009
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

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 Intervention
Refractory Ascites
Device: AFS System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal

Further study details as provided by NovaShunt AG:

Primary Outcome Measures:
  • Number of paracentesis procedures required [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: December 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Automatic Fluid Shunt Device: AFS System
AFS System with patient specific flow rate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870662

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

No publications provided

Responsible Party: NovaShunt AG
ClinicalTrials.gov Identifier: NCT00870662     History of Changes
Other Study ID Numbers: 2008-AAR-001
Study First Received: March 25, 2009
Last Updated: December 16, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Ascites
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014