NCT01528410

ALFApump System Versus Standard of Care in Ascites Treatment

ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Sequana Medical N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-08-17
• Primary completion: 2016-09-21
• Completion: 2016-09-21
• First posted: 2012-02-08
• Last updated: 2017-06-14

Locations

7 sites across 5 countries: Austria, France, Italy, Spain, United Kingdom