ALFApump System Versus Standard of Care in Ascites Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-17

Study Completion Date

2016-09-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractory or Recurrent Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a single center, open-label trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALFApump removal of ascites

Removal of ascites

Group Type EXPERIMENTAL

ALFApump removal of ascites

Intervention Type DEVICE

Implanted ALFApump, removing produced ascites according to programmed schedule

Large volume paracentesis for removal of ascites

Removal of ascites

Group Type ACTIVE_COMPARATOR

Large volume paracentesis for removal of ascites

Intervention Type PROCEDURE

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

Interventions

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ALFApump removal of ascites

Implanted ALFApump, removing produced ascites according to programmed schedule

Intervention Type DEVICE

Large volume paracentesis for removal of ascites

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

Intervention Type PROCEDURE

Other Intervention Names

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ALFApump (Automated Low Flow Ascites pump) Extraction of fluid from the abdominal cavity

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No