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

Primary Purpose

Refractory Ascites

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
AFS System
Sponsored by
NovaShunt AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Ascites

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vseobecna fakultni nemocnice v Praze
  • IKEM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Automatic Fluid Shunt

Arm Description

Outcomes

Primary Outcome Measures

Number of paracentesis procedures required

Secondary Outcome Measures

Full Information

First Posted
March 25, 2009
Last Updated
December 16, 2011
Sponsor
NovaShunt AG
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1. Study Identification

Unique Protocol Identification Number
NCT00870662
Brief Title
A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
Official Title
A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovaShunt AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automatic Fluid Shunt
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AFS System
Intervention Description
AFS System with patient specific flow rate
Primary Outcome Measure Information:
Title
Number of paracentesis procedures required
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Prague
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
IKEM
City
Prague
Country
Czech Republic

12. IPD Sharing Statement

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

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