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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Ascites
• Intervention / Treatment: Device: Alfapump

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital
• United Kingdom
  • London, United Kingdom, W120HS
    • Hammersmith Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of up to 20 patients' charts who have previously been treated with alfapump will be reviewed.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of LVP after implantation of the alfapump	The primary objective of the study is to evaluate the performance of the alfapump in reducing the need for large volume paracentesis (LVP) defined as paracentesis of five or more litres of ascites and not by pump paracentesis.	3-6 months post implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety and tolerability of alfapump in patients with malignant ascites	Device, procedure and therapy related AEs and SAEs	3-6 months post implant

Collaborators and Investigators

• Sponsor: Sequana Medical N.V.
• Investigators: Study Director: Jeroen Capel, MSc, Sequana Medical; Principal Investigator: Christina Fotopoulou, Ph.D, Hammersmith Hospitals NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ascites
• Other Study ID Numbers: 2017-AAR-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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