Evaluation of 'Melody' Paracentesis Device for Ascites Therapy
NCT ID: NCT03191851
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2016-01-04
2019-01-10
Brief Summary
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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
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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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Device
Standard device
standard device
paracentesis using standard
Melody Device
Melody device without Pump
Melody Device
paracentesis using Melody Device
Melody Device with pump
Melody Catheter device with Andromeda Pump
Melody Device with Pump
paracentesis using Melody Device with Pump
Interventions
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standard device
paracentesis using standard
Melody Device
paracentesis using Melody Device
Melody Device with Pump
paracentesis using Melody Device with Pump
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18-80 years.
* Ability to give written consent.
Exclusion Criteria
* Disseminated intravascular coagulation at the time of consenting.
* Pregnancy.
* Patients who have had more than six ascitic drainage procedures.
18 Years
80 Years
ALL
No
Sponsors
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Mediplus Ltd UK
UNKNOWN
Enteric healthcare technology Co-operative
UNKNOWN
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Guruprasad Aithal
Role: PRINCIPAL_INVESTIGATOR
NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham
Locations
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Queen Day Case Unit Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Other Identifiers
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14083
Identifier Type: -
Identifier Source: org_study_id