CClinicalTrials.gg
Sign In
CompletedNCT01528410Updated Jun 14, 2017

ALFApump System Versus Standard of Care in Ascites Treatment

A Phase 3 interventional study of ALFApump removal of ascites and Large volume paracentesis for removal of ascites in Refractory or Recurrent Ascites, sponsored by Sequana Medical N.V.. Completed at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by Sequana Medical N.V. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

02

Conditions studied

  • Refractory or Recurrent Ascites

Browse trials for

03

In context

Ascites

252 studies on the registry are indexed under Ascites; 52 are open to participants now.

This study's enrollment of 58 is close to the median of 55 across 177 interventional studies indexed under Ascites.

Browse Ascites studies →

Lead sponsor

Sequana Medical N.V. is the lead sponsor of 12 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

Inclusion criteria

  1. Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤ 1% failure rate) method of contraception during the course of the study
  2. Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria
  3. Presenting refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin).
  4. Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device

Exclusion criteria

Exclusion Criteria:

  1. Gastrointestinal haemorrhage over the last 7 days
  2. Renal failure defined as serum creatinine higher than or equal to 2 mg/dl
  3. Severe coagulopathy defined as prothrombin time greater than 40% more than upper limit of Normal (as determined locally).
  4. Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
  5. Clinical Evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
  6. Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
  7. Clinical evidence of loculated ascites.
  8. Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
  9. Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
  10. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to, cardiac pacemaker or cardioverter defibrillator.
  11. Pregnant females or females anticipating pregnancy during study period
  12. Patients currently enrolled in another interventional clinical study
  13. Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)
  14. Known presence of human immunodeficiency virus (HIV)
  15. Immuno-modulatory treatment (including azothioprine, methotrexate, anti-TNF therapies) used within last 4 months
  16. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years
  17. BMI > 40 presenting a risk for surgery and tunneled lines
  18. Patients with contraindications for general anesthesia
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    ALFApump removal of ascites

    Removal of ascites

    Device: ALFApump removal of ascites

  • Active comparator
    Large volume paracentesis for removal of ascites

    Removal of ascites

    Procedure: Large volume paracentesis for removal of ascites

Interventions

  • DeviceALFApump removal of ascites

    Implanted ALFApump, removing produced ascites according to programmed schedule

    Also known as: ALFApump (Automated Low Flow Ascites pump)

  • ProcedureLarge volume paracentesis for removal of ascites

    Large volume paracentesis - standard of care, removing ascites according to patient need

    Also known as: Extraction of fluid from the abdominal cavity

06

What researchers measure

Primary outcomes

  1. Paracentesis free survival

    Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis \> 5 litres

    Time frame: 6 months

Secondary outcomes

  1. Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system

    Cirrhosis-related complications

    Time frame: 6 months

  2. Quality of Life

    Time frame: 6 months

  3. Body weight

    Time frame: 6 months

  4. Nutritional profile

    Time frame: 6 months

  5. Resource utilisation

    Time frame: 6 months

  6. Survival

    Time frame: 6 months

  7. Assess the need for repeat evacuation paracentesis

    Time frame: 6 months

07

Study locations

7 sites
  • Vienna General Hospital and Medical School, AKH
    Vienna, Austria
  • Hopital Beaujon
    Clichy, Paris, France
  • Centre Hospitalier Universitaire de Toulouse
    Toulouse, France
  • Azienda Ospedaliera di Padova
    Padova, Italy
  • Hospital Universitari Vall d'Hebron
    Barcelona, Spain
  • Bristol Royal Infirmary
    Bristol, United Kingdom
  • Royal Free Hospital
    London, NW3 2QG, United Kingdom
08

References and documents

Publications

  • Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump(R) system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19. PubMed 29460201 ↗
  • Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump(R) system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. Erratum In: J Hepatol. 2018 Mar;68(3):630. doi: 10.1016/j.jhep.2017.12.017. J Hepatol. 2020 Mar;72(3):595-596. doi: 10.1016/j.jhep.2019.11.023. PubMed 28645737 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01528410
Lead sponsor
Sequana Medical N.V.
Responsible party
Sponsor
First posted
Feb 8, 2012
Start date
Aug 17, 2012
Primary completion
Sep 21, 2016
Completion
Sep 21, 2016
Last update
Jun 14, 2017

Study contacts

Rajiv Jalan, Professor
principal investigator · UCL Institute of Hepatology, Royal Free Hospital, London

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Ascites→

Other studies from this sponsor

Sequana Medical N.V.

Start the discussion