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

NCT01438970 | Unknown Phase 2

• 1 other identifier: 2011-AAR-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  One month

Study Arms (1)

ALFApump system implantation

OTHER

Implantation of ALFApump system

Device: ALFApump system

Interventions

ALFApump system 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.

ALFApump system implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
• Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 months.
• Written informed consent
• Ability to comply with study procedures and ability to operate the device
• Women of childbearing age should use adequate contraceptives

You may not qualify if:

• Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
• Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
• Serum bilirubin greater than 5 mg/dl.
• Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
• Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
• Recurring urinary infections, defined as 2 or more episodes over the last 6 months.
• Clinical evidence of loculated ascites.
• Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
• Previous liver transplant.
• Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
• Pregnancy
• Patients being in another clinical study that did not reach primary endpoint yet

Sponsors & Collaborators

• Sequana Medical N.V.: lead

Study Sites (1)

Hospital clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Liver Cirrhosis; Ascites

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pere Gines, MD

  Hospital Clinica Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

ES (1)