Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
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|ClinicalTrials.gov Identifier: NCT01438970|
Recruitment Status : Active, not recruiting
First Posted : September 22, 2011
Last Update Posted : August 11, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis, Liver Refractory Ascites||Device: ALFApump system||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
ALFApump system implantation
Implantation of ALFApump system
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.
- 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. [ Time Frame: One month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438970
|Barcelona, Spain, 08036|
|Principal Investigator:||Pere Gines, MD||Hospital Clinica Barcelona, Spain|