Ascites HepaticEMPATHYNCT03191851
Evaluation of 'Melody' Paracentesis Device for Ascites Therapy
A study testing standard device, Melody Device and Melody Device with Pump in people with Ascites Hepatic and Cirrhosis and Chronic Liver Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ascites Hepatic, Cirrhosis and Chronic Liver Disease
- What is being tested?
- standard device, Melody Device and Melody Device with Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2016to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ascites due to cirrhosis of the liver.
- Aged 18-80 years.
- Ability to give written consent.
Who cannot join
- Known untreated spontaneous bacterial peritonitis.
- Disseminated intravascular coagulation at the time of consenting.
- Pregnancy.
- Patients who have had more than six ascitic drainage procedures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Day Case Unit Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- standard device, Melody Device, Melody Device with Pump
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard deviceDevice
paracentesis using standard
Melody DeviceDevice
Also called Melody Catheter
paracentesis using Melody Device
Melody Device with PumpDevice
Also called Melody Catheter with Andromeda Pump
paracentesis using Melody Device with Pump
| Study group | Role | What they receive |
|---|---|---|
| Standard Device | Active comparator | Standard device Receives: Device: standard device |
| Melody Device | Experimental | Melody device without Pump Receives: Device: Melody Device |
| Melody Device with pump | Experimental | Melody Catheter device with Andromeda Pump Receives: Device: Melody Device with Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of ascites fluid drained (litres)
Amount of ascites fluid drained in one session (litres)
Measured: Up to 6 hours
Secondary outcomes (1)
Adverse Events
As reported by patients using a visual analogue scale
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start4 Jan 2016
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascites HepaticStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mediplus Ltd UK, Enteric healthcare technology Co-operative
- Responsible party
- Sponsor
- Investigators
- Guruprasad Aithal, Principal investigator, NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191851
- Sponsor's protocol ID
- 14083
- Acronym
- EMPATHY
- Status last verified
- Nov 2020
- First submitted
- 1 Dec 2016
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 'Melody' Paracentesis Device for Ascites Therapy in Patients With Cirrhosis (EMPATHY)
- ClinicalTrials.gov ID
- NCT03191851
- Acronym / sponsor ID
- EMPATHY / 14083
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Mediplus Ltd UK, Enteric healthcare technology Co-operative
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Device | Active comparator | Device: standard deviceStandard device |
| Melody Device | Experimental | Device: Melody DeviceMelody device without Pump |
| Melody Device with pump | Experimental | Device: Melody Device with PumpMelody Catheter device with Andromeda Pump |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ascites due to cirrhosis of the liver.
- Aged 18-80 years.
- Ability to give written consent.
Key exclusion criteria (4 listed)
- Known untreated spontaneous bacterial peritonitis.
- Disseminated intravascular coagulation at the time of consenting.
- Pregnancy.
- Patients who have had more than six ascitic drainage procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard deviceparacentesis using standard | Device | Standard Device |
| Melody DeviceAlso: Melody Catheterparacentesis using Melody Device | Device | Melody Device |
| Melody Device with PumpAlso: Melody Catheter with Andromeda Pumpparacentesis using Melody Device with Pump | Device | Melody Device with pump |
Primary outcome
Amount of ascites fluid drained (litres)
Time frame: Up to 6 hours
Amount of ascites fluid drained in one session (litres)
1 secondary outcome
Adverse Events
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guruprasad Aithal principal investigator
NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard device, Melody Device and Melody Device with Pump in people with Ascites Hepatic and Cirrhosis and Chronic Liver Disease, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of ascites fluid drained (litres) (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.