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

Phase 2

• Conditions: Cirrhosis, Liver; Refractory Ascites
• Interventions: Device: ALFApump system

• Registration Number: NCT01438970
• Lead Sponsor: Sequana Medical N.V.

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALFApump system implantation	ALFApump system	Implantation of ALFApump system

Primary Outcome Measures

Name	Time	Method
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.	One month

Trial Locations

Locations (1)

Hospital clinic; 🇪🇸 Barcelona, Spain