Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-31 @ 12:02 PM
Study NCT ID:
NCT05027256
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Entia Liberty: Usability Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.', 'timeFrame': '3 months', 'description': 'At least 24 of the participants are able to complete the Entia Liberty test.'}, {'measure': 'Number of participants with new severe usability problems identified.', 'timeFrame': '3 months', 'description': 'Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves'}, {'measure': 'Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)', 'timeFrame': '3 months', 'description': 'Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants recruited from the outpatients clinic at the Christie', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years old at the time of study entry\n* Can provide written informed consent\n* Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle\n* Sufficient hearing to be able to participate in a video training session\n\nExclusion Criteria:\n\n* Known inherited or acquired bleeding disorder\n* History of haematological malignancy\n* Known poorly controlled anti-coagulation\n* Inadequate use and understanding of the English language, requiring a translator\n* Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result\n* Previously taken part in the 'PERTH-2' study involving a prototype device"}, 'identificationModule': {'nctId': 'NCT05027256', 'briefTitle': 'Entia Liberty: Usability Validation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Entia Ltd'}, 'officialTitle': 'Entia Liberty: Usability Validation', 'orgStudyIdInfo': {'id': '304701'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Entia Liberty', 'type': 'DEVICE', 'description': 'Home Monitoring solution'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aylesbury', 'country': 'United Kingdom', 'facility': 'Buckinghamshire Healthcare NHS Trust', 'geoPoint': {'lat': 51.81665, 'lon': -0.81458}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entia Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}