Prospective Malignant Ascites alfapump Study, ProMAS
Research type
Research Study
Full title
Prospective study in the use of the alfapump® in the Treatment of Malignant Ascites
IRAS ID
269477
Contact name
Danny Detiege
Contact email
Sponsor organisation
Sequana medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
The purpose of the current study is to investigate the performance and safety of the alfapump for the removal of ascites in patients where the ascites is caused by malignant disease. The data collected will tell how much fluid is transported by the alfapump and if there is need for extra paracentesis. Other information collected will give information about the general well-being, nutritional status, the patients's quality of life and information concerning the safety of the implanted alfapump . This study will also analyse urine samples obtained after alfapump implantation, to explore if it is possible to assess presence of cancer cells in the urine, and to evaluate if these samples can be used for additional diagnostic tests. The study will also investigate if the general well-being may change or improve after implantation of the alfapump, and as such might influence any further anti-cancer treatment cycles.
REC name
London - South East Research Ethics Committee
REC reference
20/LO/0043
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Unfavourable Opinion