V-NAV Usability Study: End Users Trying the Vortant Indoo... | NCT05647694

Studies
V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool

NCT05647694

Sponsor

Vortant Technologies, LLC

Status

Suspended

Last Update Posted

Nov 25, 2024Actual

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Blindness and Low Vision

Interventions

V-NAV indoor navigation prototype

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Usability issues were identified with the app. Some usability enhancements are being implemented prior to continuing with the study

Expanded Access Info

Start Date

Jan 1, 2025Estimated

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Apr 30, 2025Estimated

First Submitted Date

Nov 29, 2022

First Submission Date that Met QC Criteria

Dec 9, 2022

First Posted Date

Dec 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2024

Last Update Posted Date

Nov 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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).

Subsequently, 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
V-NAV users	Experimental	Users who try the V-NAV for navigation tasks.	Other: V-NAV indoor navigation prototype

Interventions

Name	Type	Description	Arm Group Labels	Other Names
V-NAV indoor navigation prototype	Other	Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.	V-NAV users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
V-NAV effectiveness	A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
V-NAV usability	A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AFB "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees

Exclusion Criteria:

Any health condition that may affect safety of individual to participate
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip R Schaefer, M.S.E	Vortant Technologies, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vortant Technologies		Weaverville	North Carolina	28787	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001766	Blindness
D015354	Vision, Low

Ancestor Terms

ID	Term
D014786	Vision Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided