Evaluation of ‘Melody’ Paracentesis device for ascites therapy V1
Research type
Research Study
Full title
Evaluation of ‘Melody’ Paracentesis devise for Ascites Therapy in patients with cirrhosis (EMPATHY)
IRAS ID
161025
Contact name
Angela Shone
Contact email
Clinicaltrials.gov Identifier
Research summary
Ascites is the accumulation of fluid inside the abdomen. This can happen when the liver fails due to substantial amount of scarring as in cirrhosis. When there is a large amount of fluid collection it stretches and increases pressure within the abdomen. This causes pain, breathlessness and weight gain leading to a marked impairment in the activities and quality of daily life. Majority of patients with ascites will require the fluid inside the abdomen to be drained at some point; as cirrhosis progresses patients will require drainage of ascites repeatedly on a regular basis. Our current device is not specifically designed for this purpose. Performance of these devices is suboptimal; fluid drainage is slow and incomplete, hence, requiring frequent procedures to keep patient’s symptoms under control. We have designed a new ’Melody’ device specifically for the purpose of draining ascites fluid. We expect this to drain fluid faster and more completely. Performing ascites drainage using this device would be easier, and therefore the procedure should cause less discomfort and pain. The use of this device should also reduce the time spent by patient in hospital and increase time between further ascites drainage procedures. To investigate this in an unbiased manner, we will carry out a trial where we will compare ascites drainage performed by the current device, with ascites drainage performed using the new device. We will compare the volume of fluid drained by both devices as well as the length of time it takes for fluid to accumulate after each procedure. We will collect information regarding how easy the procedure is from staff and doctors performing the procedure. We will also collect feedback regarding the\nprocedure from patients undergoing ascites drainage. We will compare the frequency of all potential complications related to the procedures performed using both devices.
REC name
West of Scotland REC 4
REC reference
14/WS/1085
Date of REC Opinion
12 Nov 2014
REC opinion
Further Information Favourable Opinion