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Completed

NCT Number: NCT03191851

Evaluation of 'Melody' Paracentesis Device for Ascites Therapy

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.

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Key information

Conditions

Ascites Hepatic Cirrhosis and Chronic Liver Disease Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Day Case Unit Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ascites due to cirrhosis of the liver.
  • Aged 18-80 years.
  • Ability to give written consent.

Exclusion criteria

  • Known untreated spontaneous bacterial peritonitis.
  • Disseminated intravascular coagulation at the time of consenting.
  • Pregnancy.
  • Patients who have had more than six ascitic drainage procedures.

Treatment and study plan

standard device

Device

paracentesis using standard

Melody Device

Device

paracentesis using Melody Device

Other names: Melody Catheter

Melody Device with Pump

Device

paracentesis using Melody Device with Pump

Other names: Melody Catheter with Andromeda Pump

Primary outcomes

  1. Amount of ascites fluid drained (litres)

    Time frame: Up to 6 hours

    Amount of ascites fluid drained in one session (litres)

Secondary outcomes

  1. Adverse Events

    Time frame: Up to 7 days

    As reported by patients using a visual analogue scale

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Enteric healthcare technology Co-operative
  • Mediplus Ltd UK

Registry information

Official study title

Evaluation of 'Melody' Paracentesis Device for Ascites Therapy in Patients With Cirrhosis (EMPATHY)

Acronym: EMPATHY

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2017
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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