Back to resultsEffects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
Primary Purpose
Cirrhosis, Liver, Refractory Ascites
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
ALFApump system
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis, Liver
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hospital clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ALFApump system implantation
Arm Description
Implantation of ALFApump system
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01438970
First Posted
September 20, 2011
Last Updated
August 10, 2016
Sponsor
Sequana Medical N.V.
1. Study Identification
Unique Protocol Identification Number
NCT01438970
Brief Title
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sequana Medical N.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Refractory Ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALFApump system implantation
Arm Type
Other
Arm Description
Implantation of ALFApump system
Intervention Type
Device
Intervention Name(s)
ALFApump system
Intervention Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Gines, MD
Organizational Affiliation
Hospital Clinica Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
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