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

NCT ID: NCT01438970

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-12-31

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).

Conditions

Cirrhosis, Liver; Refractory Ascites

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALFApump system implantation

Implantation of ALFApump system

Group Type: OTHER

ALFApump system

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sequana Medical N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pere Gines, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinica Barcelona, Spain

Locations

Hospital clinic

Barcelona, , Spain

Countries

Spain

Other Identifiers

2011-AAR-003

Identifier Type: -

Identifier Source: org_study_id