Clinical trials: Refractory Ascites
Cirrhosis, Ascites
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
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.
- Trial name
- MOSAIC (NCT02400164)
- Testing
- alfapump system
- Where
- 6 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Sequana Medical N.V.
Ascites, Decompensated Cirrhosis
A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
This study evaluates the addition of BIV201 (terlipressin diacetate) as a continuous infusion in addition to standard of care (diuretics and therapeutic paracentesis) for reduction of ascites and complications in adult patients…
- Trial name
- NCT04112199
- Testing
- BIV201 continuous infusion
- Where
- 10 sites in United States
- Volunteers
- 15 people
- Sponsor
- BioVie Inc.
Refractory or Recurrent Ascites
ALFApump System Versus Standard of Care in Ascites Treatment
This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites.
- Trial name
- NCT01528410
- Testing
- ALFApump removal of ascites, Large volume paracentesis for removal of ascites
- Where
- 7 sites in Austria, France and 3 more
- Volunteers
- 58 people
- Sponsor
- Sequana Medical N.V.
Refractory Ascites
A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
The purpose of this study is to determine whether the Automatic Fluid Shunt (AFS) can reduce the number of paracentesis procedures in patients with refractory ascites.
- Trial name
- NCT00870662
- Testing
- AFS System
- Where
- 2 sites in Czechia
- Volunteers
- 7 people
- Sponsor
- NovaShunt AG
Cirrhosis, Liver, Refractory Ascites
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites.
- Trial name
- NCT01438970
- Testing
- ALFApump system
- Where
- Spain
- Volunteers
- 12 people
- Sponsor
- Sequana Medical N.V.
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
Cirrhosis, Liver, Liver Fibrosis
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2).
- Conditions
- Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic
- Trial name
- NCT05490888
- Testing
- PHIN-214 Subcutaneous injection
- Where
- 9 sites in United States
- Volunteers
- 74 people
- Sponsor
- PharmaIN
Cirrhosis, Ascites Hepatic
Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.
- Trial name
- NCT03107091
- Testing
- Terlipressin acetate continuous infusion
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- BioVie Inc.
Liver Cirrhosis, Refractory Ascites
ALFApump System Post Marketing Surveillance Registry
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
- Conditions
- Liver Cirrhosis, Refractory Ascites, Malignant Ascites
- Trial name
- 2011-AAR-004 (NCT01532427)
- Where
- 13 sites in Germany, Spain and 2 more
- Volunteers
- 100 people
- Sponsor
- Sequana Medical N.V.
Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites
Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer
The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route…
- Trial name
- NCT02540356
- Testing
- BAX69 Single-Route Arm, BAX69 Double-Route Arm
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- Baxalta now part of Shire
Liver Cirrhoses, Malignant Ascites
International Alfapump Cohort Study
This Registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from Sequana Medical AG, a Swiss Medical Device company.
- Trial name
- TOPMOST (NCT04326946)
- Testing
- Alfapump
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 400 people
- Sponsor
- Sequana Medical N.V.
Liver Cirrhosis
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein…
- Trial name
- NCT04987034
- Testing
- EchoTip® Insight™
- Where
- 3 sites in Belgium, Netherlands and 1 more
- Volunteers
- 35 people
- Sponsor
- Cook Research Incorporated
Ascites
Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)
The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites.
- Trial name
- POSEIDON (NCT03973866)
- Testing
- Alfapump
- Where
- 15 sites in United States, Canada
- Volunteers
- 110 people
- Sponsor
- Sequana Medical N.V.