International Alfapump Cohort Study (TOPMOST)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Cirrhoses; Malignant Ascites
• Intervention / Treatment: Device: Alfapump

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in Prealbumin	2 years
Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in Albumin.	2 years
Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in eGFR.	2 years
Clinical impact on liver and renal function in liver & renal blood lab panel	Clinical impact as assessed by changes in createnine.	2 years
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
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
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
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
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
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
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
Clinical impact on ECOG	change in ECOG performance scale pre- and post implant	2 years

Collaborators and Investigators

• Sponsor: Sequana Medical N.V.
• Investigators: Principal Investigator: Andrea De Gottardi, MD, Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 8, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: 2019-AAR-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No