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

This study is currently recruiting participants.
Verified January 2013 by Sequana Medical AG
Sponsor:
Information provided by (Responsible Party):
Sequana Medical AG
ClinicalTrials.gov Identifier:
NCT01438970
First received: September 20, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Liver Cirrhosis
Ascites
 Device: ALFApump system
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Sequana Medical AG:

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. [ Time Frame: One month ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: ALFApump system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438970

Contacts
Contact: Pere Gines, MD (+34) 93 227 1713 PGINES@clinic.ub.es

Locations
Spain
Hospital clinic Recruiting
Barcelona, Spain, 08036
Sponsors and Collaborators
Sequana Medical AG
Investigators
Principal Investigator: Pere Gines, MD Hospital Clinica Barcelona, Spain
  More Information

No publications provided

Responsible Party: Sequana Medical AG
ClinicalTrials.gov Identifier: NCT01438970     History of Changes
Other Study ID Numbers: 2011-AAR-003
Study First Received: September 20, 2011
Last Updated: January 29, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Departament de Salut de la Generalitat de Catalunya
Spain: Ethics Committee

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013