Evaluation of 'Melody' Paracentesis Device for Ascites Therapy (EMPATHY)

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

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.

Study Overview

• Status: Completed
• Conditions: Ascites Hepatic; Cirrhosis and Chronic Liver Disease
• Intervention / Treatment: Device: standard device; Device: Melody Device; Device: Melody Device with Pump

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

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Queen Day Case Unit Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Device; Standard device	Device: standard device; paracentesis using standard
EXPERIMENTAL: Melody Device; Melody device without Pump	Device: Melody Device; paracentesis using Melody Device; Other Names: Melody Catheter
EXPERIMENTAL: Melody Device with pump; Melody Catheter device with Andromeda Pump	Device: Melody Device with Pump; paracentesis using Melody Device with Pump; Other Names: Melody Catheter with Andromeda Pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of ascites fluid drained (litres)	Amount of ascites fluid drained in one session (litres)	Up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	As reported by patients using a visual analogue scale	Up to 7 days

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: Mediplus Ltd UK; Enteric healthcare technology Co-operative
• Investigators: Principal Investigator: Guruprasad Aithal, NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2016
• Primary Completion (ACTUAL): January 10, 2019
• Study Completion (ACTUAL): January 10, 2019

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (ACTUAL): June 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: 14083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO