Evaluation of 'Melody' Paracentesis Device for Ascites Therapy
Condition: Ascites Hepatic; Cirrhosis and Chronic Liver Disease
MeSH terms: Liver Diseases; Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional

Summary: 
      Ascites is the accumulation of fluid inside the abdomen. This can happen when the liver fails
      due to a substantial amount of scarring (cirrhosis). Patients (pts) must have this fluid
      drained and as cirrhosis progresses, patients will require drainage of ascites repeatedly on
      a regular basis, leading to frequent hospitals visits and increased complications.

      The current drainage device is slow and doesn't always drain completely so pts have to return
      repeatedly to keep symptoms under control.

      A new device (called Melody) has been developed and specifically designed for the purpose of
      draining ascites fluid, which the Investigators expect to drain faster and completely.

      This study will compare the volume of ascites drained using the new 'Melody' catheter device
      with that used in standard NHS practice. If the melody catheter device is confirmed as
      superior to the current device this would improve patient experience (less frequent visits to
      hospital and increased length of time between visits).

      With fewer procedures performed per patient, the pressure on the NHS would be greatly reduced
      in terms of time and costs.
    

Detailed description: 
      Large volume paracentesis has been established as a treatment for symptomatic ascites and is
      performed regularly in secondary care hospitals widely across the UK.

      Lack of a device specifically designed to perform paracentesis means that flow of ascites
      fluid through the catheter is not optimal leading to incomplete drainage and hence, frequent
      repeated paracentesis as well as a number of complications.

      A new 'Melody' catheter device has been designed and developed in collaboration with Mediplus
      Ltd and NIHR Enteric Bowel function Healthcare Technology Co-operative; specifically designed
      to improve the performance characteristics of paracentesis procedure.

      (The 'Melody ascites drainage catheter' including 'sterile ascetic drainage sets' is CE
      marked for clinical use). In addition, investigators would also like to confirm whether the
      addition of a pump will improve drainage with this device further.

      The Investigators propose to carry out a feasibility study, 'EMPATHY', with an aim to compare
      the performance characteristics of 'Melody' catheter device (with and without addition of
      'Andromeda' pump) with the current device. 112 patients with ascites requiring therapeutic
      paracentesis will be randomised to undergo the procedure using one of the two devices. The
      volume of ascites drained per session will be compared along with ease of insertion and
      removal as well as patient experience including all adverse events up to 7 days following the
      procedure. The outcomes of this feasibility study will inform further refinement of the
      'Melody' catheter device as well as a future large multi-centre randomised controlled trial
      evaluating the cost-effectiveness of the new 'Melody' catheter device in therapeutic
      paracentesis
    

Intervention name(s): standard device; Melody Device; Melody Device with Pump
Intervention type(s): Device; Device; Device
Intervention description(s): paracentesis using standard; paracentesis using Melody Device; paracentesis using Melody Device with Pump
Other intervention name(s): Melody Catheter; Melody Catheter with Andromeda Pump
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care