International Alfapump Cohort Study

Active, not recruiting

• Conditions: Malignant Ascites; Liver Cirrhoses

• Registration Number: NCT04326946
• Lead Sponsor: Sequana Medical N.V.

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.

Study Timeline

• Study First Submitted: 2018-06-25
• Study Start: 2018-08-14
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical impact on liver and renal function in liver & renal blood lab panel	2 years	Clinical impact as assessed by changes in createnine.
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 objective stress and inflammation parameters
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 ECOG	2 years	change in ECOG performance scale pre- and post implant
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	2 years	SF-36 (pre implant at each visit after the first month post implant)

Trial Locations

Locations (2)

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Inselspital; 🇨🇭 Bern, Switzerland