AscitesPhase 2/3PIONEERNCT01030185
Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
A Phase 2/3 study testing NovaShunt's Automated Fluid Shunt implantation in people with Ascites, run by NovaShunt AG at 9 sites in 4 countries.
Trial summary
To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance. Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites
- What is being tested?
- NovaShunt's Automated Fluid Shunt implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Feb 2010to Jun 2013
- Phase
- Phase 2/3
- 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
- Patients ≥ 18 years of age
- Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis.
- Cirrhosis of any etiology
- 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 <88mEq/d.
- Serum creatinine levels of ≤ 2.0 mg/dL for at least 7 days before study entry.
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- Total bilirubin levels of less than 3 mg/dL.
- Expected survival of greater than 6 months
- Written informed consent
- Ability to comply with study procedures and ability to operate the device.
- Women of childbearing age should use adequate contraceptives
Who cannot join
- Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
- Presence of peritoneal carcinomatosis
- Advanced hepatocellular carcinoma, demonstrated by:
- One tumor that is >5 cm diameter
- 3 or more nodules of >3 cm diameter
- Portal thrombosis
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- Other evidence of a malignant Etiology for Ascites
- Evidence of extensive ascites loculation
- Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study.
- Hepatic encephalopathy in the two weeks prior to implant
- Presence of a TIPS or surgical portosystemic shunt
- Presence of Budd-Chiari syndrome
- Previous liver transplant
- 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
- Patients being in another clinical study that did not reach primary endpoint yet
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Germany4 sites
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum
Berlin, 13353
Medizinische Klinik und Poliklinik I
Bonn, 53105
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität
Frankfurt, 60590
Universitätsklinikum Regensburg
Regensburg, 93053
Bulgaria2 sites
Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC
Sofia, 1404
Military Medical Academy, Clinica of Gastroenterology and Hepatology
Sofia, 1606
Spain2 sites
Hospital General Uneversitario de Alicante
Alicante, 03010
Hospital de la Santa Pau I Sant Creu
Barcelona, 08025
Belgium1 site
Department of hepatology, UZ Leuven, campus Gasthuisberg
Leuven, 3000
About this study
Official title: A Prospective, Multi-center, Open Label, Non-randomized Study to Investigate the Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance.
Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
- Conditions
- Ascites
- Being tested
- NovaShunt's Automated Fluid Shunt implantation
- Keywords
- ascites, liver cirrhosis
- Medical subject headings
- Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaShunt's Automated Fluid Shunt implantationDevice
Also called NovaShunt
The Automated Fluid Shunt (AFS) Device consists of an implantable sealed housing which contains an internally powered pump with supportive electronic components and circuits, an implantable Peritoneal Catheter, implantable Bladder Catheter and a non-implantable Charger used for wireless recharging an AFS battery and collecting data from the Device.
| Study group | Role | What they receive |
|---|---|---|
| NovaShunt's Automated Fluid Shunt | Experimental | The Automated Fluid Shunt (AFS) Device Receives: Device: NovaShunt's Automated Fluid Shunt implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events
Measured: 6 months
Secondary outcomes (5)
Paracentesis requirements
Measured: 6 month
Hematology
Measured: 6 month
Incidence of hemodynamic instability
Measured: 6 month
Incidence and severity of peripheral edema
Measured: 6 month
Patient Quality of Life.
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 posted11 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionNov 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaShunt AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Such, MD, Principal investigator, Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030185
- Sponsor's protocol ID
- 2009-AAR-002
- Acronym
- PIONEER
- Status last verified
- Sep 2013
- First submitted
- 10 Dec 2009
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open Label, Non-randomized Study to Investigate the Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
- ClinicalTrials.gov ID
- NCT01030185
- Acronym / sponsor ID
- PIONEER / 2009-AAR-002
- Conditions
- Ascites
- Keywords
- ascites, liver cirrhosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NovaShunt AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Dec 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.
To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance.
Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovaShunt's Automated Fluid Shunt | Experimental | Device: NovaShunt's Automated Fluid Shunt implantationThe Automated Fluid Shunt (AFS) Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients ≥ 18 years of age
- Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis.
- Cirrhosis of any etiology
- 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 <88mEq/d.
Key exclusion criteria (20 listed)
- Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
- Presence of peritoneal carcinomatosis
- Advanced hepatocellular carcinoma, demonstrated by:
- Other evidence of a malignant Etiology for Ascites
- Evidence of extensive ascites loculation
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 |
|---|---|---|
| NovaShunt's Automated Fluid Shunt implantationAlso: NovaShuntThe Automated Fluid Shunt (AFS) Device consists of an implantable sealed housing which contains an internally powered pump with supportive electronic components and circuits, an implantable Peritoneal Catheter, implantable Bladder Catheter and a non-implantable Charger used for wireless recharging an AFS battery and collecting data from the Device. | Device | NovaShunt's Automated Fluid Shunt |
Primary outcome
The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events
Time frame: 6 months
5 secondary outcomes
Paracentesis requirements
Time frame: 6 month
Hematology
Time frame: 6 month
Incidence of hemodynamic instability
Time frame: 6 month
Incidence and severity of peripheral edema
Time frame: 6 month
Patient Quality of Life.
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 6 Sep 2013.
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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.
Jose Such, MD principal investigator
Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NovaShunt's Automated Fluid Shunt implantation in people with Ascites, run by NovaShunt AG at 9 sites in 4 countries.
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 11 inclusion and 20 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 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Bulgaria, Spain, Belgium. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events (time frame: 6 months). 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 6 Sep 2013.