Evaluation of 'Melody' Paracentesis Device for Ascites Therapy

NCT03191851 | Completed DMC

• 1 other identifier: 14083
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ascites Hepatic; Cirrhosis and Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Amount of ascites fluid drained (litres)

  Amount of ascites fluid drained in one session (litres)

  Up to 6 hours

Secondary Outcomes (1)

• Adverse Events

  Up to 7 days

Study Arms (3)

Standard Device

ACTIVE COMPARATOR

Standard device

Device: standard device

Melody Device

EXPERIMENTAL

Melody device without Pump

Device: Melody Device

Melody Device with pump

EXPERIMENTAL

Melody Catheter device with Andromeda Pump

Device: Melody Device with Pump

Interventions

standard device DEVICE

paracentesis using standard

Standard Device

Melody Device DEVICE

paracentesis using Melody Device

Also known as: Melody Catheter

Melody Device

Melody Device with Pump DEVICE

paracentesis using Melody Device with Pump

Also known as: Melody Catheter with Andromeda Pump

Melody Device with pump

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead
• Mediplus Ltd UK: collaborator
• Enteric healthcare technology Co-operative: collaborator

Study Sites (1)

Queen Day Case Unit Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guruprasad Aithal

  NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: June 19, 2017
• Study Start: January 4, 2016
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)