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Status unknownNCT01438970Updated Aug 11, 2016

Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function

A Phase 2 interventional study of ALFApump system in Cirrhosis, Liver and Refractory Ascites, sponsored by Sequana Medical N.V.. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-11.

Sponsored by Sequana Medical N.V. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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).
02

Conditions studied

  • Cirrhosis, Liver
  • Refractory Ascites
03

In context

Liver Cirrhosis

1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.

This study's planned enrollment of 12 is below the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Sequana Medical N.V. is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients > 18 years of age
  2. Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
  3. Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 months.
  4. Written informed consent
  5. Ability to comply with study procedures and ability to operate the device
  6. Women of childbearing age should use adequate contraceptives

Exclusion criteria

Exclusion Criteria:

  1. Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
  2. Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
  3. Serum bilirubin greater than 5 mg/dl.
  4. Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
  5. Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
  6. Recurring urinary infections, defined as 2 or more episodes over the last 6 months.
  7. Clinical evidence of loculated ascites.
  8. Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
  9. Previous liver transplant.
  10. Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
  11. Pregnancy
  12. Patients being in another clinical study that did not reach primary endpoint yet
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Other
    ALFApump system implantation

    Implantation of ALFApump system

    Device: ALFApump system

Interventions

  • DeviceALFApump system

    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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Hospital clinic
    Barcelona, 08036, Spain
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2011, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2011
First posted
Sep 22, 2011
Start
Sep 2011
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Aug 11, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01438970
Lead sponsor
Sequana Medical N.V.
Responsible party
Sponsor
First posted
Sep 22, 2011
Start date
Sep 2011
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Aug 11, 2016

Study contacts

Pere Gines, MD
principal investigator · Hospital Clinica Barcelona, Spain

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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