NCT00870662

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

1 year

First QC Date

March 25, 2009

Last Update Submit

December 16, 2011

Conditions

Refractory Ascites

Outcome Measures

Primary Outcomes (1)

  • Number of paracentesis procedures required

    6 month

Study Arms (1)

Automatic Fluid Shunt

EXPERIMENTAL
Device: AFS System

Interventions

AFS SystemDEVICE

AFS System with patient specific flow rate

Automatic Fluid Shunt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vseobecna fakultni nemocnice v Praze

Prague, Prague, 128 08, Czechia

Location

IKEM

Prague, Czechia

Location

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 27, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

CZ(2)