International Alfapump Cohort Study | NCT04326946

Studies
International Alfapump Cohort Study

NCT04326946

Sponsor

Sequana Medical N.V.

Status

Active, not recruiting

Last Update Posted

Nov 12, 2024Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Liver Cirrhoses
Malignant Ascites

Interventions

Alfapump

Countries

Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2018Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Jun 25, 2018

First Submission Date that Met QC Criteria

Mar 25, 2020

First Posted Date

Mar 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2024

Last Update Posted Date

Nov 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
Alfapump	Device	alfapump implementation

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea De Gottardi, MD	Insel Gruppe AG, University Hospital Bern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Leipzig		Leipzig		04103	Germany
Inselspital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

To be decided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided