Liver Cirrhoses, Malignant Ascites
Conditions
Brief summary
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.
Detailed description
In a real-world setting, all patients implanted with an alfapump system according to it's intended use, not participating in another clinical study in which the alfapump is studied.
Interventions
DEVICEAlfapump
alfapump implementation
Sponsors
Sequana Medical N.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* All patients implanted with an alfapump are eligible for this registry
Exclusion criteria
* Patients younger than 18 years * Pregnancy * Inability to operate the Smart Charger to recharge the alfapump * Participating in another study in which the alfapump is studied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient survival at 6 months post implant | 6 months post-implant | The primary outcome will be patient survival with a functional alfapump system at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess safety at 1-month post implant for procedure related incidents. | 1 month post implant | o Occurrence of adverse events considered related to implant, product or therapy by the treating physician |
| Clinical impact on liver and renal function in liver & renal blood lab panel | 2 years | Clinical impact as assessed by changes in Prealbumin |
| To assess occurrence of (major) reportable events. | 2 years | Reportable events are defined as any events per the definition in 9.1 and classified as renal event, variceal bleeding, hepatic encephalopathy an infection or assessed as related (not classified improbable related or cannot be attributed per the definitions below) to; the implant procedure, device or therapy by the treating physician. |
| Impact of the alfapump on ascites symptoms related quality of life on patient activity | 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant | Assess change in physical activity pre- and post implant To assess daily activity and stress level of patients for up to 48 weeks following implant |
| Clinical impact on ECOG | 2 years | change in ECOG performance scale pre- and post implant |
| Impact of the alfapump on ascites symptoms related quality of life | 2 years | Ascites Questionnaire (pre implant & at each visit after the first month post implant) |
Countries
Germany, Switzerland
Outcome results
None listed