Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-07 @ 1:52 AM
Study NCT ID:
NCT05647694
Status:
SUSPENDED
Last Update Posted:
2024-11-25
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001766', 'term': 'Blindness'}, {'id': 'D015354', 'term': 'Vision, Low'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The use of the app will not be masked.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will compare the value of the prototype app to their previous navigational experience without the app.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'whyStopped': 'Usability issues were identified with the app. Some usability enhancements are being implemented prior to continuing with the study', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'V-NAV effectiveness', 'timeFrame': '4 weeks', 'description': 'A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.'}], 'secondaryOutcomes': [{'measure': 'V-NAV usability', 'timeFrame': '1 day', 'description': 'A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blindness, indoor navigation'], 'conditions': ['Blindness and Low Vision']}, 'descriptionModule': {'briefSummary': "The study will begin with an explanatory/training session where individuals with low vision will learn to use the V-NAV (Vortant NAVigation tool) indoor navigation app, and will have the opportunity to try it for a few representative tasks. The main activity includes a take-home trial, an extended unstructured period to emulate the post-purchase experience of users, during which participants will have the opportunity to use the V-NAV in their everyday lives. Data will be collected from the users to measure the relative advantage of V-NAV compared to the user's current indoor navigation method.", 'detailedDescription': 'The introductory session, emphasizing real-world experiences, will involve a brief training session followed by simulated navigation experiences in a convenient location to the users. Participants will use V-NAV to record approximately 8 locations, then will be given instructions to find these locations again. The V-NAV prototype\'s logging software will measure distance walked and task time. Participants will complete a study-specific tool covering the relevant attributes of the V-NAV prototype, as well as a standardized tool, the NASA TLX (Task Load Index).\n\nSubsequently, participants will complete a take-home trial, during which they will be encouraged to use the V-NAV features regularly to support their everyday community navigation activities. Participants will be contacted approximately weekly with a "check-in" to answer questions and resolve any emergent technical problems. At the conclusion of the trial, a product-specific tool and an appropriate standardized tool, the PIADS (Psychosocial Impact of Assistive Devices Scale) will be administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AFB "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees\n\nExclusion Criteria:\n\n* Any health condition that may affect safety of individual to participate\n* Any physical, mental, or behavioral impairment that would provide more than minimal risk or hindering ability to comprehend the purpose of the device or otherwise to be a potential user of the V-NAV hardware or app.'}, 'identificationModule': {'nctId': 'NCT05647694', 'briefTitle': 'V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool', 'organization': {'class': 'OTHER', 'fullName': 'Vortant Technologies, LLC'}, 'officialTitle': 'V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation', 'orgStudyIdInfo': {'id': 'NEI-VNAV-2C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V-NAV users', 'description': 'Users who try the V-NAV for navigation tasks.', 'interventionNames': ['Other: V-NAV indoor navigation prototype']}], 'interventions': [{'name': 'V-NAV indoor navigation prototype', 'type': 'OTHER', 'description': 'Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.', 'armGroupLabels': ['V-NAV users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28787', 'city': 'Weaverville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vortant Technologies', 'geoPoint': {'lat': 35.69705, 'lon': -82.56069}}], 'overallOfficials': [{'name': 'Philip R Schaefer, M.S.E', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vortant Technologies, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vortant Technologies, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}