Overview

This trial is active, not recruiting.

Conditions cirrhosis, liver, refractory ascites
Treatment alfapump system
Phase phase 2
Sponsor Sequana Medical AG
Start date September 2011
End date December 2016
Trial size 12 participants
Trial identifier NCT01438970, 2011-AAR-003

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Implantation of ALFApump system
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.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Pere Gines, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sequana Medical AG.