Clinical Trials Logo
  1. Home
  2. Liver Cirrhosis
  3. NCT01532427
  4. Details
NCT01532427 Clinical Trial

ALFApump System Post Marketing Surveillance Registry

Liver Cirrhosis Clinical Trial

— 2011-AAR-004  

Official title:
ALFApump System Post Marketing Surveillance Registry, In Support of the Following Indication: Automated Removal of Excess Peritoneal Fluid Into the Urinary Bladder in Patients With Cirrhosis or Malignancy, With Persistent or Refractory Ascites

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01532427
Other study ID # 2011-AAR-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date July 8, 2019

Study information
Verified date October 2020
Source Sequana Medical N.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 8, 2019
Est. primary completion date July 8, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Refractory or recurrent ascites and liver cirrhosis or malignancy - written informed consent Exclusion Criteria: - < 18 years - pregnant - not able to use the Smart charger

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Uniklinik Dresden Dresden
Germany Klinikum der Johann Wolfgang Goethe Universität Frankfurt
Germany Universitätsklinikum des Saarlandes Homburg/Saar
Germany Universitätsklinikum Jena Jena
Germany St Georg Klinik Leipzig
Germany Universitätsklinikum Leipzig, AöR Leipzig
Germany Medizinische Klinik, Universitätsmedizin Mannheim Mannheim
Germany Uniklinik Würzburg Würzburg
Spain Hosptial Universitari Vall d'Hebron Barcelona
Switzerland Inselspital Bern
Switzerland University Clinic of Geneva (HUG) Geneva
United Kingdom The London Clinic, The liver centre London
United Kingdom Freeman Hospital Newcastle on Tyne Newcastle on Tyne

Sponsors (1)
Lead Sponsor Collaborator
Sequana Medical N.V.

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety To monitor the safety of the ALFApump System 24 months
Secondary clinical performance To monitor clinical performance of the ALFApump System 24 months
Secondary clinical impact To monitor the clinical impact of the ALFApump System 24 months
Secondary usability To assess the usability of the ALFApump System 1 month
See also
  Status Clinical Trial Phase
Recruiting NCT04533932 - Endosonographic Shear Wave Elastography for Liver Stiffness
Not yet recruiting NCT06031740 - A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids N/A
Not yet recruiting NCT06026267 - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis N/A
Not yet recruiting NCT06076330 - Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension N/A
Enrolling by invitation NCT05055713 - A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT05515861 - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Not yet recruiting NCT02710227 - Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis N/A
Not yet recruiting NCT03623360 - Functional MRI to Determine Severity of Cirrhosis
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Active, not recruiting NCT02551250 - Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Recruiting NCT02239991 - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant N/A
Enrolling by invitation NCT02256514 - Open Label Trial of Immunotherapy for Advanced Liver Cancer Phase 2
Terminated NCT02311985 - Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial N/A
Terminated NCT01937130 - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF Phase 2
Recruiting NCT01728727 - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01728688 - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01724697 - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01618890 - Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding Phase 3