Status:
UNKNOWN
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
Lead Sponsor:
Sequana Medical N.V.
Conditions:
Cirrhosis, Liver
Refractory Ascites
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 stu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01438970
Start Date
September 1 2011
End Date
December 1 2016
Last Update
August 11 2016
Active Locations (1)
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1
Hospital clinic
Barcelona, Spain, 08036