Clinical trial NCT04326946: International Alfapump Cohort Study
Official title: International Alfapump Cohort Study: in Patients With Refractory Ascites Due to Liver Cirrhosis or Malignant Ascites With a Life Expectancy of 6 Months or Less
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Cirrhoses
Malignant Ascites
Lead sponsor: Sequana Medical N.V.
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The TOPMOST will target to include, in a real-world setting, all patients implanted with an alfapump system as per intended use, not participating in another clinical study in which the alfapump is being evaluated.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient survival at 6 months post implant
timeFrame: 6 months post-implant
Secondary outcomes:
measure: To assess occurrence of (major) reportable events.
timeFrame: 2 years
measure: To assess safety at 1-month post implant for procedure related incidents.
timeFrame: 1 month post implant
measure: Clinical impact on liver and renal function in liver & renal blood lab panel
timeFrame: 2 years
measure: Clinical impact on liver and renal function in liver & renal blood lab panel
timeFrame: 2 years
measure: Clinical impact on liver and renal function in liver & renal blood lab panel
timeFrame: 2 years
measure: Clinical impact on liver and renal function in liver & renal blood lab panel
timeFrame: 2 years
measure: Impact of the alfapump on ascites symptoms related quality of life
timeFrame: 2 years
measure: Impact of the alfapump on ascites symptoms related quality of life
timeFrame: 2 years
measure: Impact of the alfapump on ascites symptoms related quality of life on patient activity
timeFrame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
measure: Impact of the alfapump on ascites symptoms related quality of life on patient activity
timeFrame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
measure: Impact of the alfapump on ascites symptoms related quality of life on patient activity
timeFrame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
measure: Impact of the alfapump on ascites symptoms related quality of life on patient activity
timeFrame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
measure: Impact of the alfapump on ascites symptoms related quality of life on patient activity
timeFrame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
measure: Clinical impact on ECOG
timeFrame: 2 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Andrea De Gottardi, MD
role: PRINCIPAL_INVESTIGATOR
References: