Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-26 @ 10:22 PM
Study NCT ID:
NCT04933461
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The true failure rate of the tested devices.', 'timeFrame': 'At time of testing, up to 90 minutes'}, {'measure': "Effectiveness of the safety lancet's sharps injury prevention features.", 'timeFrame': 'At time of testing, up to 90 minutes', 'description': 'Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents\' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.'}], 'secondaryOutcomes': [{'measure': "Evaluation of the safety of the devices based on the evaluators' assessments.", 'timeFrame': 'At time of testing, up to 90 minutes ]'}, {'measure': 'Evaluation of various aspects of the ease of use.', 'timeFrame': 'At time of testing, up to 90 minutes ]'}, {'measure': 'Detection of any handling, usability questions / issues associated with the device.', 'timeFrame': 'At time of testing, up to 90 minutes ]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['safety lancet', 'capillary blood sampling', 'accidental needle-stick injury'], 'conditions': ['Accident Injury']}, 'descriptionModule': {'briefSummary': "A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.", 'detailedDescription': "This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.\n\nThe simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)\n* evaluators will be United States (US) residents\n* evaluators can read, write, and speak English\n* evaluators are at least 18 years old\n* evaluators are able to understand and provide signed consent for the study\n* evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.\n* evaluators have no concerns about the ability to perform the simulated skin pricking.\n\nExclusion Criteria:\n\n* evaluators who do not routinely use safety lancets to collect capillary blood samples,\n* evaluators who cannot read, write, and speak English,\n* evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or\n* evaluators who have participated in a product evaluation or marketing study involving safety lancets within the last six months'}, 'identificationModule': {'nctId': 'NCT04933461', 'briefTitle': "Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)", 'organization': {'class': 'INDUSTRY', 'fullName': 'HTL-Strefa S.A.'}, 'officialTitle': "Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)", 'orgStudyIdInfo': {'id': 'Test C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Simulation of skin pricking by using Medlance Plus', 'description': "Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.", 'interventionNames': ['Device: Safety lancet']}, {'type': 'OTHER', 'label': 'Simulation of skin pricking by using myLance', 'description': "Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.", 'interventionNames': ['Device: Safety lancet']}], 'interventions': [{'name': 'Safety lancet', 'type': 'DEVICE', 'description': 'There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.', 'armGroupLabels': ['Simulation of skin pricking by using Medlance Plus', 'Simulation of skin pricking by using myLance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60606', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago office', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston office', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HTL-Strefa S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}