NCT02400164View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

January 19, 2018

Study Completion Date

March 31, 2018

Conditions
CirrhosisAscites
Interventions
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.

Trial Locations (6)

Unknown

California Pacific Medical, San Francisco

Mayo Clinic, Rochester

Baylor University Healthcare System, Dallas

University of Virginia, Charlottesville

VCU Medical Centre, Richmond

M5G 1Z5

Toronto General Hospital, Toronto

All Listed Sponsors
lead

Sequana Medical N.V.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter