Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT02663635
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange", 'timeFrame': 'At time of testing, day 1'}], 'secondaryOutcomes': [{'measure': 'Ease of Use', 'timeFrame': 'At time of testing, day 1'}, {'measure': 'Evaluator assessment of device handling', 'timeFrame': 'At time of testing, day 1'}, {'measure': 'Evaluator assessment of instructions', 'timeFrame': 'At time of testing, day 1'}, {'measure': 'Evaluator assessment of improvement of device over predecessor device', 'timeFrame': 'At time of testing, day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Needle Stick']}, 'descriptionModule': {'briefSummary': "A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges", 'detailedDescription': "This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe Evaluator must be:\n\n* Minimum of age 18\n* Able to understand and provide signed consent for the study\n* Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires\n* Have no concerns about the ability to perform the simulated injections\n* With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)\n\nExclusion Criteria:\n\n* If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.'}, 'identificationModule': {'nctId': 'NCT02663635', 'briefTitle': "Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges", 'organization': {'class': 'INDUSTRY', 'fullName': 'Nemera La Verpilliere'}, 'officialTitle': "Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges", 'orgStudyIdInfo': {'id': '1550599'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'interventionNames': ["Device: Safe'N'Sound"]}], 'interventions': [{'name': "Safe'N'Sound", 'type': 'DEVICE', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55422', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'NAMSA', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Timothy Pratt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NAMSA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nemera La Verpilliere', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}