Refractory AscitesNCT00870662
A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
A study testing AFS System in people with Refractory Ascites, run by NovaShunt AG at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Ascites
- What is being tested?
- AFS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesCzechia
- Study dates
- Dec 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
Czechia2 sites
Vseobecna fakultni nemocnice v Praze
Prague, Prague, 128 08
IKEM
Prague
About this study
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.
- Conditions
- Refractory Ascites
- Being tested
- AFS System
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFS SystemDevice
AFS System with patient specific flow rate
| Study group | Role | What they receive |
|---|---|---|
| Automatic Fluid Shunt | Experimental | Not described Receives: Device: AFS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of paracentesis procedures required
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaShunt AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870662
- Sponsor's protocol ID
- 2008-AAR-001
- Status last verified
- Dec 2011
- First submitted
- 25 Mar 2009
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
- ClinicalTrials.gov ID
- NCT00870662
- Acronym / sponsor ID
- 2008-AAR-001
- Conditions
- Refractory Ascites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NovaShunt AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automatic Fluid Shunt | Experimental | Device: AFS System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFS SystemAFS System with patient specific flow rate | Device | Automatic Fluid Shunt |
Primary outcome
Number of paracentesis procedures required
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFS System in people with Refractory Ascites, run by NovaShunt AG at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of paracentesis procedures required (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.