ALFApump System Post Marketing Surveillance Registry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01532427

Acronym

2011-AAR-004

Enrollment

100

Registered

2012-02-14

Start date

2012-06-30

Completion date

2019-07-08

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Malignant Ascites, Refractory Ascites

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	24 months	To monitor the safety of the ALFApump System

Secondary

Measure	Time frame	Description
clinical performance	24 months	To monitor clinical performance of the ALFApump System
clinical impact	24 months	To monitor the clinical impact of the ALFApump System
usability	1 month	To assess the usability of the ALFApump System

Countries

Germany, Spain, Switzerland, United Kingdom

Outcome results