Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-03 @ 4:37 AM
Study NCT ID:
NCT03191851
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of 'Melody' Paracentesis Device for Ascites Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of ascites fluid drained (litres)', 'timeFrame': 'Up to 6 hours', 'description': 'Amount of ascites fluid drained in one session (litres)'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Up to 7 days', 'description': 'As reported by patients using a visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ascites Hepatic', 'Cirrhosis and Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': "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.\n\nThe current drainage device is slow and doesn't always drain completely so pts have to return repeatedly to keep symptoms under control.\n\nA 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.\n\nThis 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).\n\nWith fewer procedures performed per patient, the pressure on the NHS would be greatly reduced in terms of time and costs.", 'detailedDescription': "Large volume paracentesis has been established as a treatment for symptomatic ascites and is performed regularly in secondary care hospitals widely across the UK.\n\nLack 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.\n\nA 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.\n\n(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.\n\nThe 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ascites due to cirrhosis of the liver.\n* Aged 18-80 years.\n* Ability to give written consent.\n\nExclusion Criteria:\n\n* Known untreated spontaneous bacterial peritonitis.\n* Disseminated intravascular coagulation at the time of consenting.\n* Pregnancy.\n* Patients who have had more than six ascitic drainage procedures.'}, 'identificationModule': {'nctId': 'NCT03191851', 'acronym': 'EMPATHY', 'briefTitle': "Evaluation of 'Melody' Paracentesis Device for Ascites Therapy", 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': "Evaluation of 'Melody' Paracentesis Device for Ascites Therapy in Patients With Cirrhosis (EMPATHY)", 'orgStudyIdInfo': {'id': '14083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Device', 'description': 'Standard device', 'interventionNames': ['Device: standard device']}, {'type': 'EXPERIMENTAL', 'label': 'Melody Device', 'description': 'Melody device without Pump', 'interventionNames': ['Device: Melody Device']}, {'type': 'EXPERIMENTAL', 'label': 'Melody Device with pump', 'description': 'Melody Catheter device with Andromeda Pump', 'interventionNames': ['Device: Melody Device with Pump']}], 'interventions': [{'name': 'standard device', 'type': 'DEVICE', 'description': 'paracentesis using standard', 'armGroupLabels': ['Standard Device']}, {'name': 'Melody Device', 'type': 'DEVICE', 'otherNames': ['Melody Catheter'], 'description': 'paracentesis using Melody Device', 'armGroupLabels': ['Melody Device']}, {'name': 'Melody Device with Pump', 'type': 'DEVICE', 'otherNames': ['Melody Catheter with Andromeda Pump'], 'description': 'paracentesis using Melody Device with Pump', 'armGroupLabels': ['Melody Device with pump']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Queen Day Case Unit Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Guruprasad Aithal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust & University of Nottingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mediplus Ltd UK', 'class': 'UNKNOWN'}, {'name': 'Enteric healthcare technology Co-operative', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}