NCT03200106

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

June 23, 2017

Last Update Submit

April 5, 2018

Conditions

Malignant Ascites

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The safety and tolerability of alfapump in patients with malignant ascites

    3-6 months post implant

Interventions

AlfapumpDEVICE

Alfapump implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Inselspital

Bern, 3010, Switzerland

Location

Hammersmith Hospital

London, W120HS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31805921DERIVED

Study Officials

  • Jeroen Capel, MSc

    Sequana Medical

    STUDY DIRECTOR

  • Christina Fotopoulou, Ph.D

    Hammersmith Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 27, 2017

Study Start

August 1, 2017

Primary Completion

February 28, 2018

Study Completion

March 31, 2018

Last Updated

April 9, 2018

Record last verified: 2018-04

Locations

CH(1)GB(1)DE(1)