International Alfapump Cohort Study

NCT ID: NCT04326946

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-14

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Liver Cirrhoses Malignant Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Alfapump

alfapump implementation

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sequana Medical N.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea De Gottardi, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

Inselspital

Bern, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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2019-AAR-012

Identifier Type: -

Identifier Source: org_study_id

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