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

Malignant Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200106
• Other study ID #: 2017-AAR-011
• Status: Completed
• First received: June 23, 2017
• Last updated: April 5, 2018
• Start date: August 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Sequana Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites

Intervention

Device:
• Alfapump
Alfapump implant

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig	Leipzig
Switzerland	Inselspital	Bern
United Kingdom	Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Sequana Medical AG

Countries where clinical trial is conducted

Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The safety and tolerability of alfapump in patients with malignant ascites	Device, procedure and therapy related AEs and SAEs	3-6 months post implant