Cirrhosis, LiverPhase 2NCT01438970
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
A Phase 2 study testing ALFApump system in people with Cirrhosis, Liver and Refractory Ascites, run by Sequana Medical N.V. at 1 site in Spain.
Trial summary
This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Refractory Ascites
- What is being tested?
- ALFApump system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Dec 2016
- Phase
- Phase 2
- 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
- Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
- Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 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
- Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
- Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
- Serum bilirubin greater than 5 mg/dl.
- Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
- Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
- Recurring urinary infections, defined as 2 or more episodes over the last 6 months.
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- Clinical evidence of loculated ascites.
- Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
- Previous liver transplant.
- Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
- Pregnancy
- Patients being in another clinical study that did not reach primary endpoint yet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function in Patients With Cirrhosis and Recurrent or Refractory Ascites
This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. The secondary objectives are the following:
- To evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up.
- To investigate the effects of treatment on bacterial translocation, by means of determining bacterial DNA.
- To determine the incidence of complications associated with treatment in the course of follow-up.
- To evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease questionnaire).
- Conditions
- Cirrhosis, Liver, Refractory Ascites
- Being tested
- ALFApump system
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALFApump systemDevice
The device described above will be implanted using general anaesthesia. The device will be programmed according to each patient's individual requirements, setting the daily loss of ascitic fluid needed to maintain a stable body weight.
| Study group | Role | What they receive |
|---|---|---|
| ALFApump system implantation | Other | Implantation of ALFApump system Receives: Device: ALFApump system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pere Gines, MD, Principal investigator, Hospital Clinica Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438970
- Sponsor's protocol ID
- 2011-AAR-003
- Status last verified
- Aug 2016
- First submitted
- 20 Sep 2011
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function in Patients With Cirrhosis and Recurrent or Refractory Ascites
- ClinicalTrials.gov ID
- NCT01438970
- Acronym / sponsor ID
- 2011-AAR-003
- Conditions
- Cirrhosis, Liver, Refractory Ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Sep 2011 (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 single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. The secondary objectives are the following:
- To evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up.
- To investigate the effects of treatment on bacterial translocation, by means of determining bacterial DNA.
- To determine the incidence of complications associated with treatment in the course of follow-up.
- To evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALFApump system implantation | Other | Device: ALFApump systemImplantation of ALFApump system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients > 18 years of age
- Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
- Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 months.
- Written informed consent
- Ability to comply with study procedures and ability to operate the device
Key exclusion criteria (12 listed)
- Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
- Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
- Serum bilirubin greater than 5 mg/dl.
- Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
- Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
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 |
|---|---|---|
| ALFApump systemThe device described above will be implanted using general anaesthesia. The device will be programmed according to each patient's individual requirements, setting the daily loss of ascitic fluid needed to maintain a stable body weight. | Device | ALFApump system implantation |
Primary outcome
The main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites.
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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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.
Pere Gines, MD principal investigator
Hospital Clinica Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALFApump system in people with Cirrhosis, Liver and Refractory Ascites, run by Sequana Medical N.V. at 1 site in Spain.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. (time frame: One 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 11 Aug 2016.