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Evaluation of 'Melody' Paracentesis Device for Ascites Therapy

NCT03191851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2020-11-19

No results posted yet for this study

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

Interventions

DEVICE

standard device

paracentesis using standard

DEVICE

Melody Device

paracentesis using Melody Device

DEVICE

Melody Device with Pump

paracentesis using Melody Device with Pump

Sponsors & Collaborators

  • Mediplus Ltd UK

    collaborator UNKNOWN

  • Enteric healthcare technology Co-operative

    collaborator UNKNOWN

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Guruprasad Aithal · NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-04
Primary Completion
2019-01-10
Completion
2019-01-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03191851 on ClinicalTrials.gov