NCT01438970

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sequana Medical N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cirrhosis, Liver
• Refractory Ascites

Interventions

Type	Name	Description
DEVICE	ALFApump system	The device described above will be implanted using general anaesthesia. The device will be programmed according to each patient's individual requirements, setting the daily loss of ascitic fluid needed to maintain a stable body weight.

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2011-09-22
• Last updated: 2016-08-11

Locations

1 site across 1 country: Spain