Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites

NCT ID: NCT03200106

Last Updated: 2018-04-09

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

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-03-31

Brief Summary

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Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature.

This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.

Detailed Description

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Conditions

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Malignant Ascites

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Alfapump

Alfapump implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with malignant ascites
* Patients with alfapump implanted for malignant ascites
* Patients 18 years or older at the time of death

Exclusion Criteria

* Patient is alive at the time of inclusion assessment
Minimum Eligible Age

18 Years

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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Jeroen Capel, MSc

Role: STUDY_DIRECTOR

Sequana Medical

Christina Fotopoulou, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hammersmith Hospitals NHS Trust

Locations

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Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

Inselspital

Bern, , Switzerland

Site Status

Hammersmith Hospital

London, , United Kingdom

Site Status

Countries

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Germany Switzerland United Kingdom

References

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Fotopoulou C, Berg T, Hausen A, Hennig R, Jalan R, Malago M, Capel J, De Gottardi A, Stirnimann G. Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites. BMC Palliat Care. 2019 Dec 5;18(1):109. doi: 10.1186/s12904-019-0497-3.

Reference Type DERIVED
PMID: 31805921 (View on PubMed)

Other Identifiers

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2017-AAR-011

Identifier Type: -

Identifier Source: org_study_id

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