Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-01 @ 8:22 AM
Study NCT ID:
NCT03807635
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2019-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulated Clinical Use Testing on Safety Lancets (Test A)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016602', 'term': 'Needlestick Injuries'}], 'ancestors': [{'id': 'D014951', 'term': 'Wounds, Stab'}, {'id': 'D014950', 'term': 'Wounds, Penetrating'}, {'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': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-01-16', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-13', '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': "Subjective assessments regarding evaluators' interactions with the tested safety lancets", '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.'}, {'measure': "Safety of the devices based on the evaluators' assessments (five-point response scale)", '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 any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a "greater than" relationship.'}, {'measure': 'Various aspects of the ease of use.', '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.'}, {'measure': 'Any handling, usability questions / issues associated with the device', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['needlestick', 'needlestick injury', 'safety lancet', 'sharps injury prevention', 'capillary blood sampling'], 'conditions': ['Needle Stick']}, 'descriptionModule': {'briefSummary': "A simulated clinical use testing on the HTL-Strefa's safety lancets", 'detailedDescription': "This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices.\n\nThe simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples and lay persons."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:\n\n* (HCP evaluators only) - 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\nLay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.\n\nExclusion Criteria:\n\nHCPs:\n\n* They do not routinely use safety lancets to collect capillary blood samples,\n* They cannot read, write, and speak English,\n* They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or\n* They have participated in a product evaluation or marketing study involving safety lancets within the last six months\n\nLay people:\n\n* They cannot read, write, and speak English,\n* They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or\n* They have participated in a product evaluation or marketing study involving safety lancets within the last six months'}, 'identificationModule': {'nctId': 'NCT03807635', 'briefTitle': 'Simulated Clinical Use Testing on Safety Lancets (Test A)', '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 A)", 'orgStudyIdInfo': {'id': 'Test A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'simulation of skin pricking type 450', 'description': 'The evaluator simulated the capillary blood sampling with the safety lancet type 450', 'interventionNames': ['Device: ergoLance safety lancet']}, {'type': 'EXPERIMENTAL', 'label': 'simulation of skin pricking type 610', 'description': 'The evaluator simulated the capillary blood sampling with the safety lancet type 610', 'interventionNames': ['Device: Acti-Lance safety lancet']}], 'interventions': [{'name': 'ergoLance safety lancet', 'type': 'DEVICE', 'description': 'The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.', 'armGroupLabels': ['simulation of skin pricking type 450']}, {'name': 'Acti-Lance safety lancet', 'type': 'DEVICE', 'description': 'The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.', 'armGroupLabels': ['simulation of skin pricking type 610']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60606', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'UL LLC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Schlesinger Associates', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HTL-Strefa S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}