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

Cirrhosis, Liver Clinical Trial

Official title:
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function in Patients With Cirrhosis and Recurrent or Refractory Ascites

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01438970
Study type Interventional
Source Sequana Medical AG
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 2011
Completion date December 2016
View Details
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