NCT04326946

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Aug 2018Dec 2030

First Submitted

Initial submission to the registry

June 25, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

10.4 years

First QC Date

June 25, 2018

Last Update Submit

November 8, 2024

Conditions

Liver CirrhosesMalignant Ascites

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • To assess occurrence of (major) reportable events.

    2 years

  • To assess safety at 1-month post implant for procedure related incidents.

    1 month post implant

  • Clinical impact on liver and renal function in liver & renal blood lab panel

    2 years

  • Clinical impact on liver and renal function in liver & renal blood lab panel

    2 years

  • Clinical impact on liver and renal function in liver & renal blood lab panel

    2 years

  • +9 more secondary outcomes

Interventions

AlfapumpDEVICE

alfapump implementation

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All patients implanted with an alfapump are eligible for this registry

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Inselspital

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biobanking of urine, ascites and serum

Study Officials

  • Andrea De Gottardi, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

March 30, 2020

Study Start

August 14, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations

CH(1)DE(1)