International Alfapump Cohort Study

Liver Cirrhoses Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04326946
• Other study ID #: 2019-AAR-012
• Status: Recruiting
• Start date: August 14, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2020
• Source: Sequana Medical N.V.
• Contact: Jeroen Capel, MSc
• Phone: +41-44-4035512
• Email: jeroen.capel[@]sequanamedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Fibrosis
• Liver Cirrhoses
• Liver Cirrhosis
• Malignant Ascites

Intervention

Device:
• Alfapump
alfapump implementation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig	Leipzig
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Sequana Medical N.V.

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival at 6 months post implant	The primary outcome will be patient survival with a functional alfapump system at 6 months.	6 months post-implant
Secondary	To assess occurrence of (major) reportable events.	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.	2 years
Secondary	To assess safety at 1-month post implant for procedure related incidents.	o Occurrence of adverse events considered related to implant, product or therapy by the treating physician	1 month post implant
Secondary	Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in Prealbumin	2 years
Secondary	Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in Albumin.	2 years
Secondary	Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in eGFR.	2 years
Secondary	Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in createnine.	2 years
Secondary	Impact of the alfapump on ascites symptoms related quality of life	Ascites Questionnaire (pre implant & at each visit after the first month post implant)	2 years
Secondary	Impact of the alfapump on ascites symptoms related quality of life	SF-36 (pre implant at each visit after the first month post implant)	2 years
Secondary	Impact of the alfapump on ascites symptoms related quality of life on patient activity	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	1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Secondary	Impact of the alfapump on ascites symptoms related quality of life on patient activity	Assess change in physical activity pre- and post implant To assess and evaluate sleep of patients for up to 48 weeks following implant	1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Secondary	Impact of the alfapump on ascites symptoms related quality of life on patient activity	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; To assess and evaluate sleep of patients for up to 48 weeks following implant; To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness; To assess objective stress and inflammation parameters	1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Secondary	Impact of the alfapump on ascites symptoms related quality of life on patient activity	Assess change in physical activity pre- and post implant To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness	1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Secondary	Impact of the alfapump on ascites symptoms related quality of life on patient activity	Assess change in physical activity pre- and post implant To assess objective stress and inflammation parameters	1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Secondary	Clinical impact on ECOG	change in ECOG performance scale pre- and post implant	2 years