Liver Cirrhosis2011-AAR-004NCT01532427
ALFApump System Post Marketing Surveillance Registry
An observational study of Liver Cirrhosis and Refractory Ascites, run by Sequana Medical N.V. at 13 sites in 4 countries.
Trial summary
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis, Refractory Ascites, Malignant Ascites
- How many people
- 100 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Jun 2012to 8 Jul 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Registry will include 200 patients implanted after market approval at up to 25 centres, in patients with liver cirrhosis or malignancy, with persistent or refractory ascites.
Who may be able to join
- Refractory or recurrent ascites and liver cirrhosis or malignancy
- written informed consent
Who cannot join
- < 18 years
- pregnant
- not able to use the Smart charger
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Germany8 sites
Uniklinik Dresden
Dresden
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
Universitätsklinikum Jena
Jena, 07747
St Georg Klinik
Leipzig, 04129
Universitätsklinikum Leipzig, AöR
Leipzig
Medizinische Klinik, Universitätsmedizin Mannheim
Mannheim
Uniklinik Würzburg
Würzburg
Switzerland2 sites
Inselspital
Bern, 3010
University Clinic of Geneva (HUG)
Geneva
United Kingdom2 sites
The London Clinic, The liver centre
London
Freeman Hospital Newcastle on Tyne
Newcastle upon Tyne
About this study
Official title: ALFApump System Post Marketing Surveillance Registry, In Support of the Following Indication: Automated Removal of Excess Peritoneal Fluid Into the Urinary Bladder in Patients With Cirrhosis or Malignancy, With Persistent or Refractory Ascites
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
- Conditions
- Liver Cirrhosis, Refractory Ascites, Malignant Ascites
- Medical subject headings
- Liver Cirrhosis, Ascites
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
To monitor the safety of the ALFApump System
Measured: 24 months
Secondary outcomes (3)
clinical performance
To monitor clinical performance of the ALFApump System
Measured: 24 months
clinical impact
To monitor the clinical impact of the ALFApump System
Measured: 24 months
usability
To assess the usability of the ALFApump System
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startJun 2012
- Primary completion8 Jul 2019
- Study completion8 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea De Gottardi, Privatdozent, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532427
- Sponsor's protocol ID
- 2011-AAR-004
- Acronym
- 2011-AAR-004
- Status last verified
- Oct 2020
- First submitted
- 9 Feb 2012
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Engelmann C, Herber A, Trepte C, Capel J, De Gottardi A. Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump. Liver Int. 2022 Oct;42(10):2247-2259. doi: 10.1111/liv.15337. Epub 2022 Jul 25.
PubMed 35686702Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.
PubMed 28940225
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALFApump System Post Marketing Surveillance Registry, In Support of the Following Indication: Automated Removal of Excess Peritoneal Fluid Into the Urinary Bladder in Patients With Cirrhosis or Malignancy, With Persistent or Refractory Ascites
- ClinicalTrials.gov ID
- NCT01532427
- Acronym / sponsor ID
- 2011-AAR-004 / 2011-AAR-004
- Conditions
- Liver Cirrhosis, Refractory Ascites, Malignant Ascites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2012 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 14 Feb 2012 (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.
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Registry will include 200 patients implanted after market approval at up to 25 centres, in patients with liver cirrhosis or malignancy, with persistent or refractory ascites.
Key inclusion criteria (2 listed)
- Refractory or recurrent ascites and liver cirrhosis or malignancy
- written informed consent
Key exclusion criteria (3 listed)
- < 18 years
- pregnant
- not able to use the Smart charger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety
Time frame: 24 months
To monitor the safety of the ALFApump System
3 secondary outcomes
clinical performance
Time frame: 24 months
clinical impact
Time frame: 24 months
usability
Time frame: 1 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 26 Oct 2020.
- Derived from this study: PubMed 35686702Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Engelmann C, Herber A, Trepte C, Capel J, De Gottardi A. Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump. Liver Int. 2022 Oct;42(10):2247-2259. doi: 10.1111/liv.15337. Epub 2022 Jul 25.
- Derived from this study: PubMed 28940225Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.
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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.
Andrea De Gottardi, Privatdozent principal investigator
Insel Gruppe AG, University Hospital Bern
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Refractory Ascites, run by Sequana Medical N.V. at 13 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 2 inclusion and 3 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 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Switzerland, United Kingdom, Spain. 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?
Safety (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01532427, which also lists 2 linked publications.
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 26 Oct 2020.