NCT02400164

A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sequana Medical N.V. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.

Conditions

• Cirrhosis
• Ascites

Interventions

Type	Name	Description
DEVICE	alfapump system	The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-01-19
• Completion: 2018-03-31
• First posted: 2015-03-26
• Last updated: 2018-04-06

Locations

6 sites across 2 countries: United States, Canada