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ALFApump System Versus Standard of Care in Ascites Treatment

NCT01528410 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-06-14

No results posted yet for this study

Summary

This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis \> 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

Conditions

  • Refractory or Recurrent Ascites

Interventions

DEVICE

ALFApump removal of ascites

Implanted ALFApump, removing produced ascites according to programmed schedule

PROCEDURE

Large volume paracentesis for removal of ascites

Large volume paracentesis - standard of care, removing ascites according to patient need

Sponsors & Collaborators

  • Sequana Medical N.V.

    lead INDUSTRY

Principal Investigators

  • Rajiv Jalan, Professor · UCL Institute of Hepatology, Royal Free Hospital, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-17
Primary Completion
2016-09-21
Completion
2016-09-21

Countries

  • Austria
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528410 on ClinicalTrials.gov